K142204 is an FDA 510(k) clearance for the Bioceptive Suction Cervical Retractor, a Tenaculum, Uterine (Class II — Special Controls, product code HDC), submitted by Bioceptive, Inc. (New Orleans, US). The FDA issued a Cleared decision on December 19, 2014, 130 days after receiving the submission on August 11, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K142204 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 11, 2014 |
| Decision Date | December 19, 2014 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HDC — Tenaculum, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |