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FDA 510(k)

Disposable Polymer Ligation Clips

K-Number: K250643 · 2025-11-20

ApplicantHangzhou Kangji Medical Instrument Co., Ltd.
Decision Date2025-11-20
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Polymer Ligation Clips is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Kangji Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K250643. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Polymer Ligation Clips?

Disposable Polymer Ligation Clips is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Hangzhou Kangji Medical Instrument Co., Ltd.. The 510(k) number is K250643.

When did Disposable Polymer Ligation Clips receive FDA 510(k) clearance?

Disposable Polymer Ligation Clips received FDA 510(k) clearance on 2025-11-20, under 510(k) number K250643.

Who is the listed applicant for Disposable Polymer Ligation Clips?

The FDA 510(k) record lists Hangzhou Kangji Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Polymer Ligation Clips?

The FDA product code for Disposable Polymer Ligation Clips is FZP.

Other records listing Hangzhou Kangji Medical Instrument Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233263Disposable TrocarsK232401Disposable Veress Needles

Related Devices (Code: FZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex MedicalK242541GEM ZIPCLIPSynovis Micro Companies Alliance A Subsidiary of Baxter IntK221495SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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