Cleared Traditional

K171225 - Sorbact Wound Dressing-Ribbon Gauze

K171225 · Abigo Medical AB · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2017
Decision
117d
Days
-
Risk

K171225 is an FDA 510(k) clearance for the Sorbact Wound Dressing-Ribbon Gauze. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Abigo Medical AB (Askim, SE). The FDA issued a Cleared decision on August 21, 2017 after a review of 117 days - within the typical 510(k) review window.

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 - K171225

510(k) Number K171225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2017
Decision Date August 21, 2017
Days to Decision 117 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
2d slower than avg
Panel avg: 115d · This submission: 117d
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
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K171225.
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