K212911 is an FDA 510(k) clearance for the Konig Mogen Clamp, a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on November 18, 2022, 431 days after receiving the submission on September 13, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K212911 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 13, 2021 |
| Decision Date | November 18, 2022 |
| Days to Decision | 431 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 |