K010098 is an FDA 510(k) clearance for the MODIFICATION TO 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 1, 2001, 21 days after receiving the submission on January 11, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K010098 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 11, 2001 |
| Decision Date | February 01, 2001 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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 |