Cleared Traditional

K100839 - BARIREP

K100839 · Gorbec Pharmaceutical Services, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
48d
Days
-
Risk

K100839 is an FDA 510(k) clearance for the BARIREP. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Gorbec Pharmaceutical Services, Inc. (Durham, US). The FDA issued a Cleared decision on May 11, 2010 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K100839

510(k) Number K100839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2010
Decision Date May 11, 2010
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
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 685
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K100839.
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K100429 · Laboratoires Urgo · Jun 2010
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
K100430 · Laboratoires Urgo · Jun 2010
MANUKAPLI WOUND DRESSING
K092689 · Manuka Medical Limited · May 2010
VASHE WOUND THERAPY SOLUTION
K093697 · Puricore, Inc. · Apr 2010
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
K092348 · Polyremedy, Inc. · Apr 2010
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS
K092351 · Polyremedy, Inc. · Apr 2010
K100839 · BARIREP
Download PDF FDA Summary Gorbec Pharmaceutical…