K122658 is an FDA 510(k) clearance for the FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009. This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.1050. Obtains Tissue Samples From The Endocervical Canal For Histological Analysis..
| 510(k) Number | K122658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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. |