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FDA 510(k)

DONASORB SILVER WOUND DRESSING

K-Number: K153565 · 2016-09-22

ApplicantVirchow Biotech Pvt, Ltd.
Decision Date2016-09-22
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DONASORB SILVER WOUND DRESSING is a medical device manufactured by Virchow Biotech Pvt, Ltd.. It received FDA 510(k) clearance on 2016-09-22 under approval number K153565. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DONASORB SILVER WOUND DRESSING?

DONASORB SILVER WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2016-09-22. It is manufactured by Virchow Biotech Pvt, Ltd.. The 510(k) number is K153565.

When was DONASORB SILVER WOUND DRESSING approved by the FDA?

DONASORB SILVER WOUND DRESSING received FDA 510(k) clearance on 2016-09-22, under approval number K153565.

What company makes DONASORB SILVER WOUND DRESSING?

DONASORB SILVER WOUND DRESSING is manufactured by Virchow Biotech Pvt, Ltd..

What is the FDA product code for DONASORB SILVER WOUND DRESSING?

The FDA product code for DONASORB SILVER WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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 Virchow Biotech Pvt, Ltd.

K172747HYALURONIC ACID TOPICAL WOUND CREAM

Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

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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