Cleared Traditional

K943339 - GAUZE SPONGE (E.W.A. LTD./VARIOUS)

K943339 · E.W.A., Ltd. · General & Plastic Surgery device
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Aug 1994
Decision
42d
Days
-
Risk

K943339 is an FDA 510(k) clearance for the GAUZE SPONGE (E.W.A. LTD./VARIOUS). Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by E.W.A., Ltd. (Brick, US). The FDA issued a Cleared decision on August 23, 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 E.W.A., Ltd. devices

FDA 510(k) Submission Details - K943339

510(k) Number K943339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date August 23, 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.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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