Cleared Traditional

K100839 - BARIREP

K100839 · Gorbec Pharmaceutical Services, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Gorbec Pharmaceutical Services, Inc. devices

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

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