# K251882: Uterine Aspiration Set

- Pathway: 510(k) (Traditional)
- Applicant: Gcmedica Enterprise Ltd.(Wuxi)
- Decided: Oct 16, 2025 after 118 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
Longest line of descent: 2 generations back to K813282 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030935: Berkeley V-10 Vacuum Curettage System, Acmi Corporation (2003) Summary page 6.

## Indications for use
Uterine Aspiration Set is used with the vacuum system to aspirate transcervically the products of conception or menstruation from the uterus.

Source page: https://510kreport.com/device/K251882
Methodology: https://510kreport.com/methodology