# K051294: Femtest Endometrial Suction Curette, Model FT-1

- Pathway: 510(k) (Traditional)
- Applicant: Femspec LLC
- Decided: Dec 21, 2005 after 217 days
- Product code: HHK (Curette, Suction, Endometrial (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1175
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
FernSpec LLC, FemTestTM Endometrial Suction Curette is a sterile, dispsbe curette indicated for single patient use in obtaining tissue samlsfrhistological analysis from the endocervical canal and utrs. Histological analysis of the uterine mucosal lining is indicated for: * Cancer screening * Endometrial dating * Determining response to estrogen replacement therapy * Badterial culturing * Detection of pathology resulting in infertility * Monitoring patients receiving Tamoxifen therapy * Evaluating secondary amenorrhea

Source page: https://510kreport.com/device/K051294
Methodology: https://510kreport.com/methodology