Clearance Summary
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 received FDA 510(k) clearance under submission number K122658, sponsored by Femasys, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2012-12-20.
- Submission: K122658
- Applicant / Sponsor: Femasys, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1050
- Decision date: 2012-12-20
Classification & Regulation
This clearance is catalogued under FDA product code PCF and 21 CFR 884.1050, within the Obstetrics/Gynecology review panel as a Class II device.