# K172727: Hemoclip

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Apr 16, 2018 after 217 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.
8 later devices descend from it; 6 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122660: Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612, Boston Scientific Corporation (2012) Summary page 4.
- K161463: SureClip (TM) Repositionable Hemostasis Clip, Micro-Tech (Nanjing) Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K211787: Hemoclip (2022), 2 descendants of its own
- K252271: Hemoclip (2025), 0 descendants of its own
- K241005: Haemostasis Clips (2025), 0 descendants of its own
- K234124: Single Use Hemoclips (2024), 0 descendants of its own
- K232450: Disposable Hemostatic Clips (2024), 0 descendants of its own

## Indications for use
The hemoclip is indicated for endoscopic clip placement within the gastrointestinal 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 Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4. As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K172727
Methodology: https://510kreport.com/methodology