Cleared Traditional

K961775 - PROFORE FOUR-LAYER BANDAGE SYSTEM KIT

K961775 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Jul 1996
Decision
69d
Days
-
Risk

K961775 is an FDA 510(k) clearance for the PROFORE FOUR-LAYER BANDAGE SYSTEM KIT. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on July 16, 1996 after a review of 69 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 Smith & Nephew United, Inc. devices

Submission Details

510(k) Number K961775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1996
Decision Date July 16, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 38
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