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 a medical device manufactured by Synovis Micro Companies Alliance A Subsidiary of Baxter Int. It received FDA 510(k) clearance on 2025-01-15 under approval 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. It is manufactured by Synovis Micro Companies Alliance A Subsidiary of Baxter Int. The 510(k) number is K242541.

When was GEM ZIPCLIP approved by the FDA?

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

What company makes GEM ZIPCLIP?

GEM ZIPCLIP is manufactured by Synovis Micro Companies Alliance A Subsidiary of Baxter Int.

What is the FDA product code for GEM ZIPCLIP?

The FDA product code for GEM ZIPCLIP is FZP.

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Official Source

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