# K152001: Sterile Repositionable Hemostasis Clipping Device

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Dec 10, 2015 after 143 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: 5 generations back to K963160 (1997). 5 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 21 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 5.

## Most influential descendants
- K161463: SureClip (TM) Repositionable Hemostasis Clip (2017), 13 descendants of its own
- K172727: Hemoclip (2018), 8 descendants of its own
- K211787: Hemoclip (2022), 2 descendants of its own
- K201771: Single Use Rotatable and Repositionable Hemoclip (2020), 1 descendant of its own
- K172762: Single Use Hemoclip (2018), 1 descendant of its own

## Indications for use
The Sterile Repositionable Hemostasis Clipping 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.

Source page: https://510kreport.com/device/K152001
Methodology: https://510kreport.com/methodology