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Snowden-Pencer

Model SP90-7271 · STERIS CORPORATION · DI 10885403161544

GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2023-07-13Z-2429-2023Class IIOpen, ClassifiedSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.code info di

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

24572019-01: 0 reports for this device; peer average 2.42/device2019-02: 0 reports for this device; peer average 3.53/device2019-03: 0 reports for this device; peer average 2.95/device2019-04: 0 reports for this device; peer average 3.13/device2019-05: 0 reports for this device; peer average 2.46/device2019-06: 0 reports for this device; peer average 3.58/device2019-07: 0 reports for this device; peer average 2.42/device2019-08: 0 reports for this device; peer average 2.47/device2019-09: 0 reports for this device; peer average 2.47/device2019-10: 0 reports for this device; peer average 2.71/device2019-11: 0 reports for this device; peer average 2.12/device2019-12: 0 reports for this device; peer average 2.35/device2020-01: 0 reports for this device; peer average 2.55/device2020-02: 0 reports for this device; peer average 2.7/device2020-03: 0 reports for this device; peer average 2.28/device2020-04: 0 reports for this device; peer average 2.54/device2020-05: 0 reports for this device; peer average 1.98/device2020-06: 0 reports for this device; peer average 2.78/device2020-07: 0 reports for this device; peer average 2.77/device2020-08: 0 reports for this device; peer average 4.33/device2020-09: 0 reports for this device; peer average 4.4/device2020-10: 0 reports for this device; peer average 3.99/device2020-11: 0 reports for this device; peer average 4.47/device2020-12: 0 reports for this device; peer average 3.87/device2021-01: 0 reports for this device; peer average 3.99/device2021-02: 0 reports for this device; peer average 3.89/device2021-03: 0 reports for this device; peer average 4.83/device2021-04: 0 reports for this device; peer average 4.7/device2021-05: 0 reports for this device; peer average 4.05/device2021-06: 0 reports for this device; peer average 4.28/device2021-07: 0 reports for this device; peer average 3.88/device2021-08: 0 reports for this device; peer average 3.87/device2021-09: 0 reports for this device; peer average 3.91/device2021-10: 0 reports for this device; peer average 3.99/device2021-11: 0 reports for this device; peer average 3.49/device2021-12: 0 reports for this device; peer average 4.46/device2022-01: 0 reports for this device; peer average 4.57/device2022-02: 0 reports for this device; peer average 5.03/device2022-03: 0 reports for this device; peer average 5.45/device2022-04: 0 reports for this device; peer average 6.48/device2022-05: 0 reports for this device; peer average 5.46/device2022-06: 0 reports for this device; peer average 6.07/device2022-07: 0 reports for this device; peer average 6.34/device2022-08: 0 reports for this device; peer average 6.38/device2022-09: 0 reports for this device; peer average 5.53/device2022-10: 0 reports for this device; peer average 5.35/device2022-11: 0 reports for this device; peer average 5.52/device2022-12: 0 reports for this device; peer average 6/device2023-01: 0 reports for this device; peer average 5.73/device2023-02: 0 reports for this device; peer average 4.87/device2023-03: 0 reports for this device; peer average 5.86/device2023-04: 0 reports for this device; peer average 5.47/device2023-05: 0 reports for this device; peer average 5.86/device2023-06: 0 reports for this device; peer average 7.1/device2023-07: 0 reports for this device; peer average 6.1/device2023-08: 0 reports for this device; peer average 6.28/device2023-09: 0 reports for this device; peer average 5.92/device2023-10: 0 reports for this device; peer average 6.38/device2023-11: 0 reports for this device; peer average 5.76/device2023-12: 0 reports for this device; peer average 6.05/device2024-01: 0 reports for this device; peer average 5.53/device2024-02: 0 reports for this device; peer average 6.18/device2024-03: 0 reports for this device; peer average 5.56/device2024-04: 0 reports for this device; peer average 6.32/device2024-05: 0 reports for this device; peer average 5.3/device2024-06: 0 reports for this device; peer average 7.07/device2024-07: 0 reports for this device; peer average 5.75/device2024-08: 0 reports for this device; peer average 6.5/device2024-09: 0 reports for this device; peer average 6.28/device2024-10: 0 reports for this device; peer average 7.11/device2024-11: 0 reports for this device; peer average 4.55/device2024-12: 0 reports for this device; peer average 4.77/device2025-01: 0 reports for this device; peer average 4.42/device2025-02: 0 reports for this device; peer average 4.03/device2025-03: 0 reports for this device; peer average 5.17/device2025-04: 0 reports for this device; peer average 4.67/device2025-05: 0 reports for this device; peer average 4.69/device2025-06: 0 reports for this device; peer average 4.58/device2025-07: 0 reports for this device; peer average 4.68/device2025-08: 0 reports for this device; peer average 5.45/device2025-09: 0 reports for this device; peer average 3.97/device2025-10: 0 reports for this device; peer average 4.59/device2025-11: 0 reports for this device; peer average 4.86/device2025-12: 0 reports for this device; peer average 6.15/device2026-01: 0 reports for this device; peer average 4.95/device2026-02: 0 reports for this device; peer average 5.05/device2026-03: 0 reports for this device; peer average 5.77/device2026-04: 0 reports for this device; peer average 6.2/device2026-05: 0 reports for this device; peer average 5.86/device2026-06: 0 reports for this device; peer average 5.01/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.42
2019-0203.53
2019-0302.95
2019-0403.13
2019-0502.46
2019-0603.58
2019-0702.42
2019-0802.47
2019-0902.47
2019-1002.71
2019-1102.12
2019-1202.35
2020-0102.55
2020-0202.7
2020-0302.28
2020-0402.54
2020-0501.98
2020-0602.78
2020-0702.77
2020-0804.33
2020-0904.4
2020-1003.99
2020-1104.47
2020-1203.87
2021-0103.99
2021-0203.89
2021-0304.83
2021-0404.7
2021-0504.05
2021-0604.28
2021-0703.88
2021-0803.87
2021-0903.91
2021-1003.99
2021-1103.49
2021-1204.46
2022-0104.57
2022-0205.03
2022-0305.45
2022-0406.48
2022-0505.46
2022-0606.07
2022-0706.34
2022-0806.38
2022-0905.53
2022-1005.35
2022-1105.52
2022-1206
2023-0105.73
2023-0204.87
2023-0305.86
2023-0405.47
2023-0505.86
2023-0607.1
2023-0706.1
2023-0806.28
2023-0905.92
2023-1006.38
2023-1105.76
2023-1206.05
2024-0105.53
2024-0206.18
2024-0305.56
2024-0406.32
2024-0505.3
2024-0607.07
2024-0705.75
2024-0806.5
2024-0906.28
2024-1007.11
2024-1104.55
2024-1204.77
2025-0104.42
2025-0204.03
2025-0305.17
2025-0404.67
2025-0504.69
2025-0604.58
2025-0704.68
2025-0805.45
2025-0903.97
2025-1004.59
2025-1104.86
2025-1206.15
2026-0104.95
2026-0205.05
2026-0305.77
2026-0406.2
2026-0505.86
2026-0605.01
This device (reports/month)Average device in GCJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K930667 — cited as predicate by K092684, K110257, K151036

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — STERIS CORPORATION

  • Warning Letter 2015-02-20 Key Surgical LLC
  • Warning Letter 2014-05-22 Isomedix Operations, Inc.
  • Warning Letter 2012-05-29 Albert Browne Ltd.
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2010-09-27 Isomedix Operations, Inc.
  • Injunction 2010-04-20 Steris Corporation
  • Injunction 2010-04-20 Steris Corporation
  • Warning Letter 2009-07-31 Medivators Inc
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-03 Isomedix Operations Inc. · 0 citations
  • NAI 2026-03-12 Isomedix Operations Inc · 0 citations
  • VAI 2026-02-26 Steris S.p.A. · 1 citations
  • VAI 2026-02-12 Synergy Health Ede BV · 2 citations
  • NAI 2026-02-12 Synergy Health Marseille · 0 citations
  • OAI 2025-12-12 Black Diamond Video Inc. · 3 citations
  • VAI 2025-08-01 STERIS Laboratories, Inc. · 2 citations
  • NAI 2025-06-18 Isomedix Operations Inc. · 0 citations
  • NAI 2025-06-17 Isomedix Operations Inc · 0 citations
  • NAI 2025-06-05 Isomedix Operations, Inc. · 0 citations
  • NAI 2025-04-01 Steris Corporation · 0 citations
  • NAI 2025-02-21 Isomedix Operations Inc. · 0 citations
  • NAI 2025-01-23 Synergy Health Allershausen GmbH · 0 citations
  • VAI 2024-12-12 Isomedix Operations, Inc · 0 citations
  • NAI 2024-12-05 Steris (Synergy Health Ede BV) · 0 citations
  • VAI 2024-11-21 Steris Applied Sterilization Technologies ULC · 2 citations
  • NAI 2024-09-23 Isomedix Operations, Inc. · 0 citations
  • NAI 2024-09-19 Isomedix Operations, Inc. · 0 citations