Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

SDC3

Model 0240060100 · STRYKER CORPORATION · DI 07613327056150

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

HRX — Arthroscope · Class II · 21 CFR 888.1100

UDILibrary device dossier · generated 2026-09-12 · 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 (82)

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.

Malfunction: 81 · Injury: 1

24682019-01: 4 reports for this device; peer average 7.08/device2019-02: 0 reports for this device; peer average 3.45/device2019-03: 0 reports for this device; peer average 3.23/device2019-04: 1 reports for this device; peer average 3.53/device2019-05: 1 reports for this device; peer average 3.07/device2019-06: 0 reports for this device; peer average 3.61/device2019-07: 0 reports for this device; peer average 2.74/device2019-08: 1 reports for this device; peer average 3.03/device2019-09: 0 reports for this device; peer average 3.21/device2019-10: 0 reports for this device; peer average 3.53/device2019-11: 0 reports for this device; peer average 3.04/device2019-12: 1 reports for this device; peer average 3.15/device2020-01: 0 reports for this device; peer average 3.46/device2020-02: 5 reports for this device; peer average 3.59/device2020-03: 1 reports for this device; peer average 3.32/device2020-04: 3 reports for this device; peer average 3.38/device2020-05: 1 reports for this device; peer average 2.77/device2020-06: 1 reports for this device; peer average 3.77/device2020-07: 2 reports for this device; peer average 3.67/device2020-08: 0 reports for this device; peer average 4.8/device2020-09: 0 reports for this device; peer average 5.62/device2020-10: 1 reports for this device; peer average 5.6/device2020-11: 1 reports for this device; peer average 5.07/device2020-12: 4 reports for this device; peer average 5.81/device2021-01: 1 reports for this device; peer average 4.82/device2021-02: 2 reports for this device; peer average 4.61/device2021-03: 2 reports for this device; peer average 6.05/device2021-04: 5 reports for this device; peer average 5.29/device2021-05: 0 reports for this device; peer average 4.67/device2021-06: 0 reports for this device; peer average 4.79/device2021-07: 2 reports for this device; peer average 4.25/device2021-08: 1 reports for this device; peer average 4.26/device2021-09: 1 reports for this device; peer average 3.76/device2021-10: 1 reports for this device; peer average 4.35/device2021-11: 1 reports for this device; peer average 3.58/device2021-12: 2 reports for this device; peer average 4.74/device2022-01: 0 reports for this device; peer average 4.68/device2022-02: 1 reports for this device; peer average 4.66/device2022-03: 1 reports for this device; peer average 5.12/device2022-04: 1 reports for this device; peer average 5.69/device2022-05: 2 reports for this device; peer average 5.08/device2022-06: 1 reports for this device; peer average 5.46/device2022-07: 0 reports for this device; peer average 5.77/device2022-08: 0 reports for this device; peer average 5.72/device2022-09: 1 reports for this device; peer average 5.05/device2022-10: 1 reports for this device; peer average 5.01/device2022-11: 2 reports for this device; peer average 5.22/device2022-12: 5 reports for this device; peer average 5.62/device2023-01: 0 reports for this device; peer average 5.56/device2023-02: 0 reports for this device; peer average 4.73/device2023-03: 4 reports for this device; peer average 5.68/device2023-04: 2 reports for this device; peer average 5.29/device2023-05: 3 reports for this device; peer average 5.59/device2023-06: 2 reports for this device; peer average 6.21/device2023-07: 0 reports for this device; peer average 5.47/device2023-08: 2 reports for this device; peer average 5.94/device2023-09: 1 reports for this device; peer average 5.58/device2023-10: 2 reports for this device; peer average 5.75/device2023-11: 0 reports for this device; peer average 6.37/device2023-12: 3 reports for this device; peer average 6.93/device2024-01: 1 reports for this device; peer average 5.76/device2024-02: 1 reports for this device; peer average 6.29/device2024-03: 0 reports for this device; peer average 5.47/device2024-04: 0 reports for this device; peer average 6.21/device2024-05: 0 reports for this device; peer average 6.22/device2024-06: 0 reports for this device; peer average 7.63/device2024-07: 0 reports for this device; peer average 5.51/device2024-08: 0 reports for this device; peer average 6.04/device2024-09: 0 reports for this device; peer average 5.78/device2024-10: 1 reports for this device; peer average 6.83/device2024-11: 0 reports for this device; peer average 4.76/device2024-12: 0 reports for this device; peer average 5.69/device2025-01: 0 reports for this device; peer average 5.65/device2025-02: 0 reports for this device; peer average 4.71/device2025-03: 0 reports for this device; peer average 5.14/device2025-04: 0 reports for this device; peer average 4.89/device2025-05: 0 reports for this device; peer average 5.07/device2025-06: 0 reports for this device; peer average 4.75/device2025-07: 0 reports for this device; peer average 4.87/device2025-08: 0 reports for this device; peer average 5.09/device2025-09: 0 reports for this device; peer average 4.18/device2025-10: 0 reports for this device; peer average 4.75/device2025-11: 0 reports for this device; peer average 5.1/device2025-12: 0 reports for this device; peer average 6.08/device2026-01: 0 reports for this device; peer average 5.11/device2026-02: 0 reports for this device; peer average 5.21/device2026-03: 0 reports for this device; peer average 5.71/device2026-04: 0 reports for this device; peer average 6.43/device2026-05: 0 reports for this device; peer average 5.5/device2026-06: 0 reports for this device; peer average 4.97/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0147.08
2019-0203.45
2019-0303.23
2019-0413.53
2019-0513.07
2019-0603.61
2019-0702.74
2019-0813.03
2019-0903.21
2019-1003.53
2019-1103.04
2019-1213.15
2020-0103.46
2020-0253.59
2020-0313.32
2020-0433.38
2020-0512.77
2020-0613.77
2020-0723.67
2020-0804.8
2020-0905.62
2020-1015.6
2020-1115.07
2020-1245.81
2021-0114.82
2021-0224.61
2021-0326.05
2021-0455.29
2021-0504.67
2021-0604.79
2021-0724.25
2021-0814.26
2021-0913.76
2021-1014.35
2021-1113.58
2021-1224.74
2022-0104.68
2022-0214.66
2022-0315.12
2022-0415.69
2022-0525.08
2022-0615.46
2022-0705.77
2022-0805.72
2022-0915.05
2022-1015.01
2022-1125.22
2022-1255.62
2023-0105.56
2023-0204.73
2023-0345.68
2023-0425.29
2023-0535.59
2023-0626.21
2023-0705.47
2023-0825.94
2023-0915.58
2023-1025.75
2023-1106.37
2023-1236.93
2024-0115.76
2024-0216.29
2024-0305.47
2024-0406.21
2024-0506.22
2024-0607.63
2024-0705.51
2024-0806.04
2024-0905.78
2024-1016.83
2024-1104.76
2024-1205.69
2025-0105.65
2025-0204.71
2025-0305.14
2025-0404.89
2025-0505.07
2025-0604.75
2025-0704.87
2025-0805.09
2025-0904.18
2025-1004.75
2025-1105.1
2025-1206.08
2026-0105.11
2026-0205.21
2026-0305.71
2026-0406.43
2026-0505.5
2026-0604.97
This device (reports/month)Average device in GCJ, HRX (reports/device/month)

Regulatory clearances

  • K160332 SESE 2016-05-18 (k number procode)

Predicate lineage

K160332 — cites (transitively): K121893 (d1) — cited as predicate by K181258, K210584

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

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
  • NAI 2026-06-18 International Life Sciences · 0 citations
  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations