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FDA 510(k)

GeniPhys Collymer Self-Assembling Scaffold

K-Number: K250329 · 2025-06-25

ApplicantGeniphys, Inc.
Decision Date2025-06-25
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

GeniPhys Collymer Self-Assembling Scaffold is a medical device manufactured by Geniphys, Inc.. It received FDA 510(k) clearance on 2025-06-25 under approval number K250329. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GeniPhys Collymer Self-Assembling Scaffold?

GeniPhys Collymer Self-Assembling Scaffold is a medical device that received FDA 510(k) clearance on 2025-06-25. It is manufactured by Geniphys, Inc.. The 510(k) number is K250329.

When was GeniPhys Collymer Self-Assembling Scaffold approved by the FDA?

GeniPhys Collymer Self-Assembling Scaffold received FDA 510(k) clearance on 2025-06-25, under approval number K250329.

What company makes GeniPhys Collymer Self-Assembling Scaffold?

GeniPhys Collymer Self-Assembling Scaffold is manufactured by Geniphys, Inc..

What is the FDA product code for GeniPhys Collymer Self-Assembling Scaffold?

The FDA product code for GeniPhys Collymer Self-Assembling Scaffold is KGN.

Related Devices (Code: KGN)

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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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