Cleared Traditional

K831917 - VILENE COTTON GAUZE II

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.

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FDA 510(k) Submission Details - K831917

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.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K831917.
STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
K852202 · Ormed Mfg., Inc. · Jun 1985
WET PACK
K843783 · E.M. Adams · Dec 1984
DRY TRAY
K843782 · E.M. Adams · Dec 1984
FLORET STRUNG GAUZE SPONGES
K830261 · Ritmed, Inc. · Jun 1983
FLORET KITTNER OR K DISSECTOR
K830266 · Ritmed, Inc. · Jun 1983
FLORET SPECIAL GAUZE SPONGES
K830267 · Ritmed, Inc. · Jun 1983