K172661 is an FDA 510(k) clearance for the Fetzer Medical Gynecological Forceps, a Forceps, Surgical, Gynecological (Class II — Special Controls, product code HCZ), submitted by Fetzer Medical GmbH & Co. KG (Tuttlingen, DE). The FDA issued a Cleared decision on May 8, 2018, 245 days after receiving the submission on September 5, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K172661 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 2017 |
| Decision Date | May 08, 2018 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HCZ — Forceps, Surgical, Gynecological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |