Cleared Traditional

ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES (K865095) - FDA 510(k) Clearance

K865095 · Kor-Medical Industries, Ltd. · General & Plastic Surgery device
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Jan 1987
Decision
21d
Days
-
Risk

K865095 is an FDA 510(k) clearance for the ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Kor-Medical Industries, Ltd. (Chicago, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 21 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 Kor-Medical Industries, Ltd. devices

Submission Details

510(k) Number K865095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1986
Decision Date January 20, 1987
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 11
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K865095.
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · Johnson & Johnson Professionals, Inc. · Mar 1988
PHARMANET (TM)
K872572 · Pharmacia, Inc. · Jan 1988
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982
POST OP. SPONGES STERILE
K802860 · Abco Dealers, Inc. · Dec 1980
COMBINATION PADS STERILE SINGLES
K802861 · Abco Dealers, Inc. · Dec 1980