Cleared Traditional

K864175 - SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES

K864175 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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Nov 1986
Decision
12d
Days
-
Risk

K864175 is an FDA 510(k) clearance for the SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Fraass Survival Systems, Inc. (Bronx, US). The FDA issued a Cleared decision on November 5, 1986 after a review of 12 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

FDA 510(k) Submission Details - K864175

510(k) Number K864175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1986
Decision Date November 05, 1986
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K864175.
FRASTEC DRY BURN DRESSING
K871916 · Fraass Survival Systems, Inc. · Jun 1987
FRASTEC DRY GAUZE BANDAGE
K871917 · Fraass Survival Systems, Inc. · Jun 1987
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52
K871438 · Fraass Survival Systems, Inc. · May 1987
GAUZE, ABSORBENT, STERILE, COMPRESSED
K863932 · Fraass Survival Systems, Inc. · Oct 1986
BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES
K863713 · Fraass Survival Systems, Inc. · Oct 1986
BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES
K863714 · Fraass Survival Systems, Inc. · Oct 1986