# K172762: Single Use Hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decided: Mar 20, 2018 after 188 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)
- K152001: Sterile Repositionable Hemostasis Clipping Device, Micro-Tech (Nanjing) Co., Ltd. (2015) Summary page 4.
- K161463: SureClip (TM) Repositionable Hemostasis Clip, Micro-Tech (Nanjing) Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K212669: Single Use Hemoclip (2022), 0 descendants of its own

## Indications for use
The Single Use Hemoclip device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: (1) endoscopic marking, (2) hemostasis for (a) mucosal / sub-mucosal defects < 3cm, (b) bleeding ulcers, (c) polyps < 1.5cm in diameter, (d) diverticula in the colon, (3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively (4) the age of the intended population for the device is for patients who are 18 and older.

Source page: https://510kreport.com/device/K172762
Methodology: https://510kreport.com/methodology