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FDA 510(k)

Maxiocel Chitosan Wound Dressing

K-Number: K212766 · 2023-08-24

ApplicantAdvamedica, Inc.
Decision Date2023-08-24
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Maxiocel Chitosan Wound Dressing is a medical device manufactured by Advamedica, Inc.. It received FDA 510(k) clearance on 2023-08-24 under approval number K212766. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maxiocel Chitosan Wound Dressing?

Maxiocel Chitosan Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Advamedica, Inc.. The 510(k) number is K212766.

When was Maxiocel Chitosan Wound Dressing approved by the FDA?

Maxiocel Chitosan Wound Dressing received FDA 510(k) clearance on 2023-08-24, under approval number K212766.

What company makes Maxiocel Chitosan Wound Dressing?

Maxiocel Chitosan Wound Dressing is manufactured by Advamedica, Inc..

What is the FDA product code for Maxiocel Chitosan Wound Dressing?

The FDA product code for Maxiocel Chitosan Wound Dressing is KGN.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_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 NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) 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 Advamedica, Inc.

K172324Axiostat Chitosan Hemostatic Dressing K202830Axiostat Patch K222909Axiostat Gauze K213198Ax-Surgi Surgical Hemostat

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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