Cleared Traditional

K013056 - GELCLAIR CONCENTRATED ORAL GEL (FDA 510(k) Clearance)

K013056 · Sinclair Pharmaceuticals, Ltd. · General & Plastic Surgery device
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Dec 2001
Decision
101d
Days
-
Risk

K013056 is an FDA 510(k) clearance for the GELCLAIR CONCENTRATED ORAL GEL. Classified as Oral Wound Dressing (product code OLR).

Submitted by Sinclair Pharmaceuticals, Ltd. (Chinley, High Peak, GB). The FDA issued a Cleared decision on December 21, 2001 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sinclair Pharmaceuticals, Ltd. devices

Submission Details

510(k) Number K013056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2001
Decision Date December 21, 2001
Days to Decision 101 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
13d faster than avg
Panel avg: 114d · This submission: 101d
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.