Cleared Traditional

K062795 - MUGARD MUCOADHESIVE ORAL WOUND RINSE

K062795 · Access Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
84d
Days
-
Risk

K062795 is an FDA 510(k) clearance for the MUGARD MUCOADHESIVE ORAL WOUND RINSE. Classified as Oral Wound Dressing (product code OLR).

Submitted by Access Pharmaceuticals, Inc. (Dallas, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 84 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 Access Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K062795

510(k) Number K062795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date December 11, 2006
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 34
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K062795.
ULCELOOCIN ORAL ULCER PATCH
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GENGIGEL MOUTHRINSE
K053342 · Ricerfarma Srl · Mar 2007
SOCK IT! ORAL PAIN GEL
K063148 · Merlin Group Dba Mcmerlin Dental Company · Jan 2007
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
K060363 · Hemcon, Inc. · Jul 2006
ORAMAGIC PLUS ORAL WOUND RINSE
K060340 · Mpm Medical., Inc. · May 2006
ALOCLAIR ORAL SPRAY
K042722 · Sinclair Pharmaceuticals, Ltd. · Jan 2005