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FDA 510(k)

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus

K-Number: K251845 · 2025-07-16

ApplicantKerecis Limited
Decision Date2025-07-16
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus is a medical device manufactured by Kerecis Limited. It received FDA 510(k) clearance on 2025-07-16 under approval number K251845. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus?

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus is a medical device that received FDA 510(k) clearance on 2025-07-16. It is manufactured by Kerecis Limited. The 510(k) number is K251845.

When was Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus approved by the FDA?

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus received FDA 510(k) clearance on 2025-07-16, under approval number K251845.

What company makes Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus?

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus is manufactured by Kerecis Limited.

What is the FDA product code for Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus?

The FDA product code for Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus is KGN.

Related Clinical Trials

NCT07549737 Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management COMPLETED NCT05461157 Preoperative Silicone Ointment and Wound Healing ENROLLING_BY_INVITATION

Other Devices by Kerecis Limited

K153364Kerecis SecureMesh K190528MariGen Wound Extra K192612Kerecis Gingiva Graft K202430Kerecis Reconstruct K213231Kerecis Silicone K241080Kerecis Parvus (50207)

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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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