Cleared Traditional

GAUZE SPONGE (K936095) - FDA 510(k) Clearance

K936095 · Dukal Corp. · General & Plastic Surgery device
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Feb 1994
Decision
42d
Days
-
Risk

K936095 is an FDA 510(k) clearance for the GAUZE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dukal Corp. (Palm Harbor, US). The FDA issued a Cleared decision on February 2, 1994 after a review of 42 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 Dukal Corp. devices

Submission Details

510(k) Number K936095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1993
Decision Date February 02, 1994
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -