# K201771: Single Use Rotatable and Repositionable Hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Anrei Medical (Hangzhou) Co., Ltd.
- Decided: Oct 19, 2020 after 112 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963160 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161463: SureClip (TM) Repositionable Hemostasis Clip, Micro-Tech (Nanjing) Co., Ltd. (2017) Summary page 5.
- K152001: Sterile Repositionable Hemostasis Clipping Device, Micro-Tech (Nanjing) Co., Ltd. (2015) Summary page 6.

## Most influential descendants
- K213217: Disposable hemoclip (2022), 0 descendants of its own

## Indications for use
Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) Hemostasis for: Mucosal/sub-mucosal defects < 3cm, Bleeding ulcers, Arteries < 2mm, Polyps < 1.5cm in diameter, Diverticula in the colon, 3) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively

Source page: https://510kreport.com/device/K201771
Methodology: https://510kreport.com/methodology