K151095 is an FDA 510(k) clearance for the Circumplast Circumcision Device, a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Novadien Healthcare (Mount Lewis, AU). The FDA issued a Cleared decision on September 18, 2015, 148 days after receiving the submission on April 23, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K151095 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 2015 |
| Decision Date | September 18, 2015 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFX — Clamp, Circumcision |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |