Cleared Traditional

K013056 - GELCLAIR CONCENTRATED ORAL GEL

K013056 · Sinclair Pharmaceuticals, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K013056

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
14d faster than avg
Panel avg: 115d · This submission: 101d
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 35
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K013056.
ORAMAGIC PLUS ORAL WOUND RINSE
K060340 · Mpm Medical., Inc. · May 2006
ALOCLAIR ORAL SPRAY
K042722 · Sinclair Pharmaceuticals, Ltd. · Jan 2005
MUCOTROL CONCENTRATED ORAL GEL WAFER
K042400 · Belcher Pharmaceuticals, Inc. · Nov 2004
ALOE THERAPY ORAL RINSE
K983182 · Carrington Laboratories, Inc. · Dec 1998
RADIACARE ORAL WOUND RINSE
K964852 · Carrington Laboratories, Inc. · Mar 1997