510(k) K232618 ยท GWG Endoscope, Neurological
Aurora Surgiscope System
| Applicant | Rebound Therapeutics Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 27, 2023 |
| Received | Aug 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232618
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2024 | Integra LifeSciences Corp. AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager. Open, Classified |
GWG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.