Disposable Polymer Ligation Clips— 510(k) K250643

Name: FDA 510(k) clearance K250643
Creator: U.S. Food and Drug Administration
Published: 2025-11-20

Substantially Equivalent

Hangzhou Kangji Medical Instrument Co., Ltd.

FDA 510(k) clearance K250643 for Disposable Polymer Ligation Clips, Substantially Equivalent on 2025-11-20. Applicant: Hangzhou Kangji Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou Kangji Medical Instrument Co., Ltd.
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2025-03-04
Decision date: 2025-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZP

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K254231 — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips2026-07-20
K253781 — InnoClip Clip Applier2025-12-22
K253903 — InnoClip Disposable Clip Applier2025-12-22
K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips2025-07-03
K242541 — GEM ZIPCLIP2025-01-15

More clearances from Hangzhou Kangji Medical Instrument Co., Ltd.

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K233263 — Disposable Trocars2024-04-09
K232401 — Disposable Veress Needles2023-12-14

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.