510(k) K945297 ยท GCJ Laparoscope, General & Plastic Surgery
INFRA VISION IMAGING SYSTEM
| Applicant | Gabriel Medical, Inc., Lafayette LA, US |
| Decision | Substantially Equivalent, Dec 20, 1994 |
| Received | Oct 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2011 | Stryker Endoscopy InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system.
Intended use:Medical device for human use, durin Terminated |
FGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.