Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ReyaGel (RG03 - MTP gel 3mL)

K-Number: K232204 · 2024-04-19

ApplicantFettech
Decision Date2024-04-19
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

ReyaGel (RG03 - MTP gel 3mL) is a medical device manufactured by Fettech. It received FDA 510(k) clearance on 2024-04-19 under approval 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. It is manufactured by Fettech. The 510(k) number is K232204.

When was ReyaGel (RG03 - MTP gel 3mL) approved by the FDA?

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

What company makes ReyaGel (RG03 - MTP gel 3mL)?

ReyaGel (RG03 - MTP gel 3mL) is manufactured by Fettech.

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)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

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.

↑