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FDA 510(k)

Collagen Wound Dressing

K-Number: K231152 · 2023-10-12

ApplicantWinner Medical Co., Ltd.
Decision Date2023-10-12
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Collagen Wound Dressing is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-10-12 under approval number K231152. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Collagen Wound Dressing?

Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-10-12. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K231152.

When was Collagen Wound Dressing approved by the FDA?

Collagen Wound Dressing received FDA 510(k) clearance on 2023-10-12, under approval number K231152.

What company makes Collagen Wound Dressing?

Collagen Wound Dressing is manufactured by Winner Medical Co., Ltd..

What is the FDA product code for Collagen Wound Dressing?

The FDA product code for Collagen Wound Dressing is KGN.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING

Other Devices by Winner Medical Co., Ltd.

K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border K192463PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) K221720Extra Silver Gelling Fiber Dressing K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown

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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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