K122658 is an FDA 510(k) clearance for the FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009, a Sampler, Endocervical (Class II — Special Controls, product code PCF), submitted by Femasys, Inc. (Suwanee, US). The FDA issued a Cleared decision on December 20, 2012, 111 days after receiving the submission on August 31, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1050.
| 510(k) Number | K122658 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 2012 |
| Decision Date | December 20, 2012 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PCF — Sampler, Endocervical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1050 |
| Definition | Obtains Tissue Samples From The Endocervical Canal For Histological Analysis. |