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Snowden-Pencer

Model SP8493 · STERIS CORPORATION · DI 10885403238116

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

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

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

K991928 — cited as predicate by K100109

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