Cleared Traditional

CARRASYN ORAL WOUND DRESSING (K933741) - FDA 510(k) Clearance

K933741 · Carrington Laboratories, Inc. · General & Plastic Surgery device
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May 1994
Decision
274d
Days
-
Risk

K933741 is an FDA 510(k) clearance for the CARRASYN ORAL WOUND DRESSING. Classified as Oral Wound Dressing (product code OLR).

Submitted by Carrington Laboratories, Inc. (Irving, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 274 days - an extended review 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: 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.

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Submission Details

510(k) Number K933741 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 03, 1993
Decision Date May 04, 1994
Days to Decision 274 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 115d · This submission: 274d
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.