Cleared Traditional

K872759 - AQUATULLE FINE MESH NON-ADHERING DRESSING

K872759 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Sep 1987
Decision
53d
Days
-
Risk

K872759 is an FDA 510(k) clearance for the AQUATULLE FINE MESH NON-ADHERING DRESSING. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 53 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.

FDA 510(k) Submission Details - K872759

510(k) Number K872759 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 13, 1987
Decision Date September 04, 1987
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
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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K871916 · Fraass Survival Systems, Inc. · Jun 1987
K872759 · AQUATULLE FINE MESH NON-ADHERING DRESSING
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