Cleared Traditional

K103793 - DURAFIBER AG

K103793 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
126d
Days
-
Risk

K103793 is an FDA 510(k) clearance for the DURAFIBER AG. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew, Inc. (St Petersburg, US). The FDA issued a Cleared decision on May 2, 2011 after a review of 126 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K103793

510(k) Number K103793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2010
Decision Date May 02, 2011
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 471
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K103793.
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
K110546 · Derma Sciences, Inc. · Jul 2011
ELTA WOUND CLEANSER
K103713 · Swiss American Products, Inc. · Jun 2011
EMULSION SB
K110732 · Prugen IP Holdings, Inc. · Jun 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
K110744 · B.Braun Medical, Inc. · Apr 2011
HYLATOPICPLUS CREAM
K110727 · Precision Dermatology Incorporated · Apr 2011
MANUKATEX
K110042 · Manuka Medical Limited · Mar 2011