# K171440: Berkeley VC-10 Vacuum Curettage System

- Pathway: 510(k) (Special)
- Applicant: Gyrus Acmi
- Decided: Sep 29, 2017 after 136 days
- Product code: HHI (System, Abortion, Vacuum)
- Device class: 2
- Regulation: 21 CFR 884.5070
- Recalls of this device: 1 (0 Class I)
- 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 4.

## Recalls of this device
- Sep 16, 2022 · Class II · Z-0078-2023: Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of co

## Indications for use
For rapid transcervical aspiration of the uterine cavity.

Source page: https://510kreport.com/device/K171440
Methodology: https://510kreport.com/methodology