FDA 510(k)

GeniPhys Collymer Self-Assembling Scaffold

K-Number: K250329 · 2025-06-25

Decision Date2025-06-25

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

GeniPhys Collymer Self-Assembling Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Geniphys, Inc.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) 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. The listed applicant is Geniphys, Inc.. The 510(k) number is K250329.

When did GeniPhys Collymer Self-Assembling Scaffold receive FDA 510(k) clearance?

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

Who is the listed applicant for GeniPhys Collymer Self-Assembling Scaffold?

The FDA 510(k) record lists Geniphys, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

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.

K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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.