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AURORA® Surgiscope®
Model ASX15/60 · Integra Lifesciences Corporation · DI 00850002332254
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 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2025-02-06
Z-1295-2025
Class II
Open, Classified
Possibility for the obturator to break (separate).
code info di
Adverse-event reports — MAUDE (1)
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: 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2
2019-03
0
1
2019-04
0
1.5
2019-05
0
1
2019-06
0
1
2019-08
0
1
2019-09
0
1
2020-01
0
3
2020-02
0
3
2020-03
0
4
2020-04
0
3
2020-05
0
2
2020-08
0
1
2020-10
0
1.5
2020-11
0
3
2020-12
0
2
2021-02
0
3
2021-03
0
1.33
2021-04
0
2
2021-05
0
5.5
2021-07
0
2
2021-08
0
2
2021-09
0
3
2021-10
0
2
2021-11
0
1.5
2021-12
0
2
2022-04
0
1.67
2022-06
0
1
2022-08
0
3.67
2022-09
0
2.5
2022-10
0
1
2022-11
0
2
2023-01
0
2
2023-02
0
1
2023-03
0
3
2023-04
0
3
2023-05
0
2.5
2023-06
0
3
2023-07
0
1
2023-08
0
1
2023-09
0
2
2023-10
0
2.5
2023-11
0
1.33
2023-12
0
1
2024-01
0
1
2024-02
0
4
2024-03
0
2
2024-04
0
2
2024-05
0
2
2024-06
0
1.5
2024-07
0
2
2024-09
1
1
2024-10
0
2.5
2024-11
0
1
2025-01
0
1.33
2025-02
0
2.83
2025-03
0
3.67
2025-04
0
2.67
2025-05
0
2.33
2025-06
0
1.8
2025-07
0
4
2025-08
0
3.33
2025-09
0
1.25
2025-10
0
1.33
2025-11
0
1.33
2025-12
0
2.56
2026-01
0
3.67
2026-02
0
2.71
2026-03
0
1.7
2026-04
0
4.6
2026-05
0
2.5
2026-06
0
1.5
This device (reports/month)Average device in GWG, GZT (reports/device/month)
Regulatory clearances
K250752 SESE 2025-04-09 (k number procode)
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