# K122658: Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009

- Pathway: 510(k) (Traditional)
- Applicant: Femasys, Inc.
- Decided: Dec 20, 2012 after 111 days
- Product code: PCF (Sampler, Endocervical)
- Device class: 2
- Regulation: 21 CFR 884.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060320 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060320: Femecc Endocervical Curette, Femspec LLC (2006) Summary page 1.

## Indications for use
The Femasys FemCerv is a sterile, disposable endlocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include: further evaluation of an abnormal Pap smear; cervical lesions extending into the endocervical canal; undiagnosed uterine bleeding.

Source page: https://510kreport.com/device/K122658
Methodology: https://510kreport.com/methodology