Cleared Traditional

MUCOTROL CONCENTRATED ORAL GEL WAFER (K042400) - FDA 510(k) Clearance

K042400 · Belcher Pharmaceuticals, Inc. · General & Plastic Surgery device
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Nov 2004
Decision
82d
Days
-
Risk

K042400 is an FDA 510(k) clearance for the MUCOTROL CONCENTRATED ORAL GEL WAFER. Classified as Oral Wound Dressing (product code OLR).

Submitted by Belcher Pharmaceuticals, Inc. (Largo, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 82 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 Belcher Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K042400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2004
Decision Date November 24, 2004
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.