K041732 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 Blue Torch Medical Technologies (Ashland, US). The FDA issued a Cleared decision on September 21, 2004, 88 days after receiving the submission on June 25, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K041732 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 25, 2004 |
| Decision Date | September 21, 2004 |
| Days to Decision | 88 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 |