Cleared Traditional

K082856 - CARAPASTE ORAL WOUND DRESSING

K082856 · Mcgrath Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
16d
Days
-
Risk

K082856 is an FDA 510(k) clearance for the CARAPASTE ORAL WOUND DRESSING. Classified as Oral Wound Dressing (product code OLR).

Submitted by Mcgrath Pharmaceuticals, Inc. (Grayslake, US). The FDA issued a Cleared decision on October 15, 2008 after a review of 16 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 - K082856

510(k) Number K082856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date October 15, 2008
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

OLR Device Classification - Class 0,

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 42
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K082856.
BENACEL
K090612 · Unicare Biomedical · Jul 2009
GELX ORAL GEL
K081372 · Bmg Pharma, LLC · Feb 2009
REXASTOM ORAL EASE
K082553 · Rexaderm, Inc. · Nov 2008
ULCELOOCIN ORAL ULCER PATCH
K070842 · Sunshine International Group, Inc. · Jun 2007
GENGIGEL MOUTHRINSE
K053342 · Ricerfarma Srl · Mar 2007
SOCK IT! ORAL PAIN GEL
K063148 · Merlin Group Dba Mcmerlin Dental Company · Jan 2007
K082856 · CARAPASTE ORAL WOUND DRESSING
Download PDF FDA Summary Mcgrath Pharmaceutica…