Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Virchow Biotech Pvt, Ltd.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) 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. The listed applicant is Virchow Biotech Pvt, Ltd.. The 510(k) number is K153565.

When did DONASORB SILVER WOUND DRESSING receive FDA 510(k) clearance?

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

Who is the listed applicant for DONASORB SILVER WOUND DRESSING?

The FDA 510(k) record lists Virchow Biotech Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07066254The Mepilex Cesarean Delivery TrialWITHDRAWNNCT07316192Pelashield™ PainGuard™ vs Restrata® in HS SurgeryRECRUITINGNCT07758855Nanotechnological Silver-Coated Dressing in Diabetic Foot UlcersCOMPLETED

Other records listing Virchow Biotech Pvt, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172747HYALURONIC ACID TOPICAL WOUND CREAM

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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.

↑