Cleared Traditional

K250643 - Disposable Polymer Ligation Clips (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250643 · Hangzhou Kangji Medical Instrument Co., Ltd. · General & Plastic Surgery device
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Nov 2025
Decision
261d
Days
Class 2
Risk

K250643 is an FDA 510(k) clearance for the Disposable Polymer Ligation Clips. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Hangzhou Kangji Medical Instrument Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 20, 2025 after a review of 261 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hangzhou Kangji Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K250643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2025
Decision Date November 20, 2025
Days to Decision 261 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 114d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Shanghai Lingfu Technology Co., Ltd.
Esther Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FZP Clip, Implantable

All 175
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K250643.
InnoClip Clip Applier
K253781 · Taiwan Surgical Corporation · Dec 2025
InnoClip Disposable Clip Applier
K253903 · Taiwan Surgical Corporation · Dec 2025
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
K251054 · Teleflex Medical · Jul 2025
GEM ZIPCLIP
K242541 · Synovis Micro Companies Alliance A Subsidiary of Baxter Int · Jan 2025
SOLID CLIP™ Single Use Clip Applier
K221495 · Medscope Biotech Co., Ltd. · Jul 2024
Hem-o-lok® Ligating Clips
K232970 · Teleflex Medical · Jan 2024