Cleared Traditional

VILENE COTTON GAUZE II (K831917) - FDA 510(k) Clearance

K831917 · Hall-Tech · General & Plastic Surgery device
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Sep 1983
Decision
104d
Days
-
Risk

K831917 is an FDA 510(k) clearance for the VILENE COTTON GAUZE II. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Hall-Tech (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hall-Tech devices

Submission Details

510(k) Number K831917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1983
Decision Date September 26, 1983
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
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 K831917.
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