Disposable Polymer Ligation Clips

FDA 510(k) K250643 · Hangzhou Kangji Medical Instrument Co., Ltd.

Substantially Equivalent

510(k) numberK250643

Submission

Device name
Disposable Polymer Ligation Clips
Applicant
Hangzhou Kangji Medical Instrument Co., Ltd.
Hangzhou, CN
Received
March 4, 2025
Decision date
November 20, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FZP – Clip, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code FZP

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K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsFZP · Traditional Taiwan Surgical Corporation07/20/2026SE
K253903InnoClip Disposable Clip ApplierFZP · Special Taiwan Surgical Corporation12/22/2025SE
K253781InnoClip Clip ApplierFZP · Special Taiwan Surgical Corporation12/22/2025SE
K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsFZP · Traditional Teleflex Medical07/03/2025SE
K242541Gem ZipclipFZP · Traditional Synovis Micro Companies Alliance A Subsidiary of…01/15/2025SE
K221495SOLID CLIP™ Single Use Clip ApplierFZP · Traditional Medscope Biotech Co., Ltd.07/18/2024SE
K232970Hem-o-lok® Ligating ClipsFZP · Traditional Teleflex Medical01/12/2024SE
K230966angiOCCLUDE Ligating ClipsFZP · Traditional A2 Medical Systems, LLC09/19/2023SE
K232313LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special Ethicon Endo Surgery, LLC08/29/2023SE
K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)FZP · Special Teleflex Medical04/28/2023SE

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Questions and answers

When was Disposable Polymer Ligation Clips cleared by the FDA?

Disposable Polymer Ligation Clips (K250643) received a 510(k) decision of Substantially Equivalent on November 20, 2025, 261 days after the submission was received.

What is the product code of K250643?

The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.