Cleared Traditional

K933308 - DYNAREX GAUZE SPONGE OR PADS (FDA 510(k) Clearance)

K933308 · Dynarex Corp. · General & Plastic Surgery device
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Dec 1993
Decision
168d
Days
-
Risk

K933308 is an FDA 510(k) clearance for the DYNAREX GAUZE SPONGE OR PADS. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on December 22, 1993 after a review of 168 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 K933308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1993
Decision Date December 22, 1993
Days to Decision 168 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 114d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -