AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)— 510(k) K250752

Name: FDA 510(k) clearance K250752
Creator: U.S. Food and Drug Administration
Published: 2025-04-09

Substantially Equivalent

Integra LifeSciences Corporation

FDA 510(k) clearance K250752 for AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80), Substantially Equivalent on 2025-04-09. Applicant: Integra LifeSciences Corporation. Device class: 2.

Clearance details

Applicant: Integra LifeSciences Corporation
Product code: Code GWG
Device class: Class 2
Regulation: 21 CFR 882.1480
Advisory panel: Neurology
Date received: 2025-03-12
Decision date: 2025-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWG

view all

K253602 — Precision S 4K Sinuscope2026-06-04
K253679 — Hydro Irrigation System2026-05-08
K243429 — HJY VisualNext 3D Endoscopic Vision System2025-05-21
K233391 — cCeLL - In vivo2024-08-21
K223615 — Digital ClarusScope System, Digital NeuroPEN System2023-11-21

More clearances from Integra LifeSciences Corporation

view all

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.