Cleared Traditional

THE SALICEPT ORAL PATCH (K012126) - FDA 510(k) Clearance

K012126 · Carrington Laboratories, Inc. · General & Plastic Surgery device
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Oct 2001
Decision
89d
Days
-
Risk

K012126 is an FDA 510(k) clearance for the THE SALICEPT ORAL PATCH. Classified as Oral Wound Dressing (product code OLR).

Submitted by Carrington Laboratories, Inc. (Irving, US). The FDA issued a Cleared decision on October 3, 2001 after a review of 89 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 Carrington Laboratories, Inc. devices

Submission Details

510(k) Number K012126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2001
Decision Date October 03, 2001
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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.