# K254050: Manual Tissue Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou AcuVu Medical Technology Co., Ltd.
- Decided: May 15, 2026 after 149 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K953695 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173901: MyoSure MANUAL Tissue Removal Device, Hologic, Inc. (2018) Summary page 5.

## Indications for use
Manual Tissue Removal Device is intended for use to perform tissue resection and removal within uterine cavity, including focal lesions such as polyps and retained products of conception.

Source page: https://510kreport.com/device/K254050
Methodology: https://510kreport.com/methodology