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FDA 510(k)

LUOFUCON® Collagen Particles (Collagen Wound Dressing)

K-Number: K232796 · 2024-04-25

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2024-04-25
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

LUOFUCON® Collagen Particles (Collagen Wound Dressing) is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-04-25 under approval number K232796. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUOFUCON® Collagen Particles (Collagen Wound Dressing)?

LUOFUCON® Collagen Particles (Collagen Wound Dressing) is a medical device that received FDA 510(k) clearance on 2024-04-25. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K232796.

When was LUOFUCON® Collagen Particles (Collagen Wound Dressing) approved by the FDA?

LUOFUCON® Collagen Particles (Collagen Wound Dressing) received FDA 510(k) clearance on 2024-04-25, under approval number K232796.

What company makes LUOFUCON® Collagen Particles (Collagen Wound Dressing)?

LUOFUCON® Collagen Particles (Collagen Wound Dressing) is manufactured by Huizhou Foryou Medical Devices Co., Ltd..

What is the FDA product code for LUOFUCON® Collagen Particles (Collagen Wound Dressing)?

The FDA product code for LUOFUCON® Collagen Particles (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 Huizhou Foryou Medical Devices Co., Ltd.

K160022LUOFUCON Silicone Ag foam dressing K170077LUOFUCON Silicone Ag Foam Dressing with Border K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing K173196SUNTOUCH Dental Dressing K201852Surgical Mask-Model Number: Ear Loop, Flat-Pleated K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)

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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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