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FDA 510(k)

Kerecis Silicone

K-Number: K213231 · 2022-06-29

ApplicantKerecis Limited
Decision Date2022-06-29
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Kerecis Silicone is a medical device manufactured by Kerecis Limited. It received FDA 510(k) clearance on 2022-06-29 under approval number K213231. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kerecis Silicone?

Kerecis Silicone is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Kerecis Limited. The 510(k) number is K213231.

When was Kerecis Silicone approved by the FDA?

Kerecis Silicone received FDA 510(k) clearance on 2022-06-29, under approval number K213231.

What company makes Kerecis Silicone?

Kerecis Silicone is manufactured by Kerecis Limited.

What is the FDA product code for Kerecis Silicone?

The FDA product code for Kerecis Silicone is KGN.

Other Devices by Kerecis Limited

K153364Kerecis SecureMesh K190528MariGen Wound Extra K192612Kerecis Gingiva Graft K202430Kerecis Reconstruct K241080Kerecis Parvus (50207) K251845Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus

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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.

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