# K182556: SureClip Repositionable Hemostasis Clip

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Dec 14, 2018 after 88 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.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151802: Resolution Clip, Boston Scientific Corporation (2015) Summary page 5.

## Most influential descendants
- K193424: Resolution 360™ ULTRA Clip (2020), 4 descendants of its own
- K222503: Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip (2022), 2 descendants of its own
- K253734: Taurus Clip (2026), 0 descendants of its own
- K250066: Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) (2025), 0 descendants of its own
- K222146: Disposable Endoscopic Hemoclip (2023), 0 descendants of its own

## Indications for use
The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope 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, (e) Arteries < 2 mm (f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection; (3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K182556
Methodology: https://510kreport.com/methodology