FDA 510(k)

ReyaGel (RG03 - MTP gel 3mL)

K-Number: K232204 · 2024-04-19

Decision Date2024-04-19

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

ReyaGel (RG03 - MTP gel 3mL) is the device name listed in this FDA 510(k) record. The listed applicant is Fettech. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K232204. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReyaGel (RG03 - MTP gel 3mL)?

ReyaGel (RG03 - MTP gel 3mL) is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Fettech. The 510(k) number is K232204.

When did ReyaGel (RG03 - MTP gel 3mL) receive FDA 510(k) clearance?

ReyaGel (RG03 - MTP gel 3mL) received FDA 510(k) clearance on 2024-04-19, under 510(k) number K232204.

Who is the listed applicant for ReyaGel (RG03 - MTP gel 3mL)?

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

What is the FDA product code for ReyaGel (RG03 - MTP gel 3mL)?

The FDA product code for ReyaGel (RG03 - MTP gel 3mL) 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.