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FDA 510(k)

SurgiAid® Collagen Wound Dressing

K-Number: K223126 · 2023-10-11

ApplicantMaxigen Biotech, Inc.
Decision Date2023-10-11
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SurgiAid® Collagen Wound Dressing is a medical device manufactured by Maxigen Biotech, Inc.. It received FDA 510(k) clearance on 2023-10-11 under approval number K223126. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiAid® Collagen Wound Dressing?

SurgiAid® Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-10-11. It is manufactured by Maxigen Biotech, Inc.. The 510(k) number is K223126.

When was SurgiAid® Collagen Wound Dressing approved by the FDA?

SurgiAid® Collagen Wound Dressing received FDA 510(k) clearance on 2023-10-11, under approval number K223126.

What company makes SurgiAid® Collagen Wound Dressing?

SurgiAid® Collagen Wound Dressing is manufactured by Maxigen Biotech, Inc..

What is the FDA product code for SurgiAid® Collagen Wound Dressing?

The FDA product code for SurgiAid® 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

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Maxigen Biotech, Inc.

K230529HealiAid Dental Collagen Wound Dressing K242100SurgiAid Collagen Wound Dressing (HA)

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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