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

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 a medical device manufactured by Abigo Medical AB. It received FDA 510(k) clearance on 2016-07-01 under approval 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. It is manufactured by Abigo Medical AB. The 510(k) number is K153674.

When was Sorbact Foam Gentle Border, Sorbact Superabsorbent approved by the FDA?

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

What company makes Sorbact Foam Gentle Border, Sorbact Superabsorbent?

Sorbact Foam Gentle Border, Sorbact Superabsorbent is manufactured by Abigo Medical AB.

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.

Related Clinical Trials

NCT07549737 Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management COMPLETED

Other Devices by Abigo Medical AB

K171225Sorbact Wound Dressing-Ribbon Gauze

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.

↑