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FDA 510(k)

Sorbact Foam Gentle Border, Sorbact Superabsorbent

K-Number: K153674 · 2016-07-01

ApplicantAbigo Medical AB
Decision Date2016-07-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Sorbact Foam Gentle Border, Sorbact Superabsorbent 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 2016-07-01 under 510(k) number K153674. 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 Foam Gentle Border, Sorbact Superabsorbent?

Sorbact Foam Gentle Border, Sorbact Superabsorbent is a medical device that received FDA 510(k) clearance on 2016-07-01. The listed applicant is Abigo Medical AB. The 510(k) number is K153674.

When did Sorbact Foam Gentle Border, Sorbact Superabsorbent receive FDA 510(k) clearance?

Sorbact Foam Gentle Border, Sorbact Superabsorbent received FDA 510(k) clearance on 2016-07-01, under 510(k) number K153674.

Who is the listed applicant for Sorbact Foam Gentle Border, Sorbact Superabsorbent?

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 Foam Gentle Border, Sorbact Superabsorbent?

The FDA product code for Sorbact Foam Gentle Border, Sorbact Superabsorbent is FRO. This falls under the Anesthesiology category.

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 Gauze

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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