Cleared Traditional

DUKAL NON-WOVEN GAUZE (K940440) - FDA 510(k) Clearance

K940440 · Dukal Corp. · General & Plastic Surgery device
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Mar 1994
Decision
37d
Days
-
Risk

K940440 is an FDA 510(k) clearance for the DUKAL NON-WOVEN GAUZE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dukal Corp. (Palm Harbor, US). The FDA issued a Cleared decision on March 9, 1994 after a review of 37 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 K940440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1994
Decision Date March 09, 1994
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -