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FDA 510(k)

Sorbact Wound Dressing-Ribbon Gauze

K-Number: K171225 · 2017-08-21

ApplicantAbigo Medical AB
Decision Date2017-08-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Sorbact Wound Dressing-Ribbon Gauze is the device name listed in this FDA 510(k) record. The listed applicant is Abigo Medical AB. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171225. 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 Sorbact Wound Dressing-Ribbon Gauze?

Sorbact Wound Dressing-Ribbon Gauze is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is Abigo Medical AB. The 510(k) number is K171225.

When did Sorbact Wound Dressing-Ribbon Gauze receive FDA 510(k) clearance?

Sorbact Wound Dressing-Ribbon Gauze received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171225.

Who is the listed applicant for Sorbact Wound Dressing-Ribbon Gauze?

The FDA 510(k) record lists Abigo Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sorbact Wound Dressing-Ribbon Gauze?

The FDA product code for Sorbact Wound Dressing-Ribbon Gauze 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.

NCT07758855Nanotechnological Silver-Coated Dressing in Diabetic Foot UlcersCOMPLETED

Other records listing Abigo Medical AB 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.

K153674Sorbact Foam Gentle Border, Sorbact Superabsorbent

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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