# K062563: Femten Cervical Tenaculum

- Pathway: 510(k) (Traditional)
- Applicant: Fem Suite, LLC
- Decided: May 18, 2007 after 260 days
- Product code: HDC (Tenaculum, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The FemSuite, LLC, FemTenTM Cervical Tenaculum is a sterile, disposable, manual instrument indicated for single patient use to hold and manipulate the cervix. This device is typically used in conjunction with endometrial biopsy.

Source page: https://510kreport.com/device/K062563
Methodology: https://510kreport.com/methodology