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AURORA® Surgiscope®

Model ICB/ASX15 · Integra Lifesciences Corporation · DI 00850002332261

GWG — Endoscope, Neurological · Class II · 21 CFR 882.1480

GZT — Retractor, Self-Retaining, For Neurosurgery · Class II · 21 CFR 882.4800

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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2024-06-07Z-2331-2024Class IIOpen, ClassifiedPotential sheath damage that could lead to tissue damage and/or track hemorrhage.k number procode

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.

13462019-01: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 4/device2020-04: 0 reports for this device; peer average 3/device2020-05: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 1.33/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 5.5/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1.67/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 3.67/device2022-09: 0 reports for this device; peer average 2.5/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 3/device2023-05: 0 reports for this device; peer average 2.5/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2.5/device2023-11: 0 reports for this device; peer average 1.33/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 4/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 2.5/device2024-11: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.33/device2025-02: 0 reports for this device; peer average 2.83/device2025-03: 0 reports for this device; peer average 3.67/device2025-04: 0 reports for this device; peer average 2.67/device2025-05: 0 reports for this device; peer average 2.33/device2025-06: 0 reports for this device; peer average 1.8/device2025-07: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 3.33/device2025-09: 0 reports for this device; peer average 1.25/device2025-10: 0 reports for this device; peer average 1.33/device2025-11: 0 reports for this device; peer average 1.33/device2025-12: 0 reports for this device; peer average 2.56/device2026-01: 0 reports for this device; peer average 3.67/device2026-02: 0 reports for this device; peer average 2.71/device2026-03: 0 reports for this device; peer average 1.7/device2026-04: 0 reports for this device; peer average 4.6/device2026-05: 0 reports for this device; peer average 2.5/device2026-06: 0 reports for this device; peer average 1.5/device010304050608090102030405081011120203040507080910111204060809101101020304050607080910111201020304050607091011010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0301
2019-0401.5
2019-0501
2019-0601
2019-0801
2019-0901
2020-0103
2020-0203
2020-0304
2020-0403
2020-0502
2020-0801
2020-1001.5
2020-1103
2020-1202
2021-0203
2021-0301.33
2021-0402
2021-0505.5
2021-0702
2021-0802
2021-0903
2021-1002
2021-1101.5
2021-1202
2022-0401.67
2022-0601
2022-0803.67
2022-0902.5
2022-1001
2022-1102
2023-0102
2023-0201
2023-0303
2023-0403
2023-0502.5
2023-0603
2023-0701
2023-0801
2023-0902
2023-1002.5
2023-1101.33
2023-1201
2024-0101
2024-0204
2024-0302
2024-0402
2024-0502
2024-0601.5
2024-0702
2024-0901
2024-1002.5
2024-1101
2025-0101.33
2025-0202.83
2025-0303.67
2025-0402.67
2025-0502.33
2025-0601.8
2025-0704
2025-0803.33
2025-0901.25
2025-1001.33
2025-1101.33
2025-1202.56
2026-0103.67
2026-0202.71
2026-0301.7
2026-0404.6
2026-0502.5
2026-0601.5
This device (reports/month)Average device in GWG, GZT (reports/device/month)

Regulatory clearances

  • K250752 SESE 2025-04-09 (k number procode)
  • K232618 SESE 2023-10-27 (k number procode)

Predicate lineage

K232618 — cites (transitively): K191861 (d1), K201840 (d1), K182211 (d2), K172433 (d2), K150378 (d3), K120691 (d3), K983365 (d3), K060973 (d4), K140337 (d4), K142024 (d4), K073449 (d5), K113732 (d5), K033621 (d5), K062640 (d5), K052424 (d6)

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

Manufacturer compliance record — Integra Lifesciences Corporation

  • Warning Letter 2024-12-19 Integra LifeSciences Corporation
  • Warning Letter 2024-12-19 Integra LifeSciences Corporation
  • Warning Letter 2023-07-17 TEI Biosciences, Inc.
  • Warning Letter 2019-03-06 TEI Biosciences, Inc.
  • Warning Letter 2015-05-29 TEI Biosciences, Inc.
  • Warning Letter 2013-04-26 ACell, Inc
  • Warning Letter 2013-02-13 Integra Neurosciences
  • Warning Letter 2011-12-21 Integra LifeSciences Corporation
  • Warning Letter 2011-12-21 Integra LifeSciences Corporation
  • NAI 2025-09-17 Integra LifeSciences Corporation · 0 citations
  • NAI 2025-09-17 Integra LifeSciences Corporation · 0 citations
  • NAI 2025-06-06 Integra LifeSciences Corporation · 0 citations
  • NAI 2025-06-06 Integra LifeSciences Corporation · 0 citations
  • NAI 2025-02-12 Surgical Innovation Associates Inc · 0 citations
  • OAI 2024-08-22 Integra LifeSciences Corp. (NeuroSciences) · 0 citations
  • OAI 2024-08-22 Integra LifeSciences Corporation · 0 citations
  • OAI 2024-08-22 Integra LifeSciences Corporation · 0 citations
  • OAI 2024-06-05 Integra LifeSciences Corporation · 7 citations
  • OAI 2024-06-05 Integra LifeSciences Corporation · 7 citations
  • OAI 2023-05-17 TEI Biosciences, Inc. · 7 citations
  • NAI 2023-03-24 Integra Neurosciences · 0 citations
  • VAI 2021-11-12 TEI Biosciences, Inc. · 6 citations
  • VAI 2021-07-15 Surgical Innovation Associates Inc · 0 citations
  • VAI 2019-08-23 Integra Neurosciences · 5 citations
  • NAI 2019-08-23 Integra LifeSciences Corp. (NeuroSciences) · 0 citations
  • NAI 2019-05-16 REBOUND THERAPEUTICS, CORPORATION · 0 citations
  • OAI 2018-11-02 TEI Biosciences, Inc. · 0 citations
  • VAI 2018-07-02 Integra LifeSciences Corporation · 4 citations
  • VAI 2018-07-02 Integra LifeSciences Corporation · 4 citations