Cleared Traditional

K935936 - CONFORMING ROLL

K935936 · Mcneil Healthcare, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
32d
Days
-
Risk

K935936 is an FDA 510(k) clearance for the CONFORMING ROLL. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Mcneil Healthcare, Inc. (Waterford, US). The FDA issued a Cleared decision on January 14, 1994 after a review of 32 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 Mcneil Healthcare, Inc. devices

FDA 510(k) Submission Details - K935936

510(k) Number K935936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date January 14, 1994
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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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