Cleared Traditional

BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 (K871438) - FDA 510(k) Clearance

K871438 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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May 1987
Decision
23d
Days
-
Risk

K871438 is an FDA 510(k) clearance for the BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Fraass Survival Systems, Inc. (Bronx, US). The FDA issued a Cleared decision on May 6, 1987 after a review of 23 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 Fraass Survival Systems, Inc. devices

Submission Details

510(k) Number K871438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1987
Decision Date May 06, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -