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FDA 510(k)

GEM ZIPCLIP

K-Number: K242541 · 2025-01-15

ApplicantSynovis Micro Companies Alliance A Subsidiary of Baxter Int
Decision Date2025-01-15
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GEM ZIPCLIP is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Micro Companies Alliance A Subsidiary of Baxter Int. It received FDA 510(k) clearance on 2025-01-15 under 510(k) number K242541. 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 GEM ZIPCLIP?

GEM ZIPCLIP is a medical device that received FDA 510(k) clearance on 2025-01-15. The listed applicant is Synovis Micro Companies Alliance A Subsidiary of Baxter Int. The 510(k) number is K242541.

When did GEM ZIPCLIP receive FDA 510(k) clearance?

GEM ZIPCLIP received FDA 510(k) clearance on 2025-01-15, under 510(k) number K242541.

Who is the listed applicant for GEM ZIPCLIP?

The FDA 510(k) record lists Synovis Micro Companies Alliance A Subsidiary of Baxter Int as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM ZIPCLIP?

The FDA product code for GEM ZIPCLIP is FZP.

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 CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex MedicalK221495SOLID 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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