510(k) K201840 ยท GWG Endoscope, Neurological
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
| Applicant | Rebound Therapeutics, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 4, 2020 |
| Received | Jul 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201840
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2025 | Integra LifeSciences Corp. AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80 Open, Classified |
GWG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.