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FDA 510(k)

SORBACT WOUND DRESSING

K-Number: K063059 · 2007-04-19

ApplicantAbigo Medical AB
Decision Date2007-04-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SORBACT WOUND DRESSING 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 2007-04-19 under 510(k) number K063059. 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?

SORBACT WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2007-04-19. The listed applicant is Abigo Medical AB. The 510(k) number is K063059.

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

SORBACT WOUND DRESSING received FDA 510(k) clearance on 2007-04-19, under 510(k) number K063059.

Who is the listed applicant for SORBACT WOUND DRESSING?

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?

The FDA product code for SORBACT 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.

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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.

K171225Sorbact Wound Dressing-Ribbon GauzeK153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentK100591SORBACTK920840OTOVENT

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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.

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