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FDA 510(k)

SurgiAid Collagen Wound Dressing (HA)

K-Number: K242100 · 2025-10-16

ApplicantMaxigen Biotech, Inc.
Decision Date2025-10-16
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SurgiAid Collagen Wound Dressing (HA) is a medical device manufactured by Maxigen Biotech, Inc.. It received FDA 510(k) clearance on 2025-10-16 under approval number K242100. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiAid Collagen Wound Dressing (HA)?

SurgiAid Collagen Wound Dressing (HA) is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Maxigen Biotech, Inc.. The 510(k) number is K242100.

When was SurgiAid Collagen Wound Dressing (HA) approved by the FDA?

SurgiAid Collagen Wound Dressing (HA) received FDA 510(k) clearance on 2025-10-16, under approval number K242100.

What company makes SurgiAid Collagen Wound Dressing (HA)?

SurgiAid Collagen Wound Dressing (HA) is manufactured by Maxigen Biotech, Inc..

What is the FDA product code for SurgiAid Collagen Wound Dressing (HA)?

The FDA product code for SurgiAid Collagen Wound Dressing (HA) 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 K223126SurgiAid® Collagen Wound Dressing

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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