K993436 is an FDA 510(k) clearance for the CAVERMAP SURGICAL AID, a Probe And Director, Gastro-urology (Class I — General Controls, product code FGM), submitted by Uromed Corp. (Norwood, US). The FDA issued a Cleared decision on February 11, 2000, 122 days after receiving the submission on October 12, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K993436 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 12, 1999 |
| Decision Date | February 11, 2000 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGM — Probe And Director, Gastro-urology |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.4730 |