K061539 is an FDA 510(k) clearance for the GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE. This device is classified as a Clamp, Circumcision (Class II - Special Controls, product code HFX).
Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on September 20, 2007, 472 days after receiving the submission on June 5, 2006.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K061539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2006 |
| Decision Date | September 20, 2007 |
| Days to Decision | 472 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFX — Clamp, Circumcision |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |