Cleared Traditional

K153674 - Sorbact Foam Gentle Border, Sorbact Superabsorbent

K153674 · Abigo Medical AB · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
193d
Days
-
Risk

K153674 is an FDA 510(k) clearance for the Sorbact Foam Gentle Border, Sorbact Superabsorbent. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Abigo Medical AB (Askim, SE). The FDA issued a Cleared decision on July 1, 2016 after a review of 193 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Abigo Medical AB devices

FDA 510(k) Submission Details - K153674

510(k) Number K153674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date July 01, 2016
Days to Decision 193 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 115d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Msquared Associates, Inc.
Deborah Lavoie Grayeski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRO Dressing, Wound, Drug

All 457
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DURAFIBER Ag
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