Cleared Traditional

K840946 - MICROPOROUS HYPOALLERGENIC

K840946 is the FDA 510(k) clearance for MICROPOROUS HYPOALLERGENIC by Gainor Medical. It is a Class 2 General & Plastic Surgery device (product code KGW) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K840946 · Gainor Medical · General & Plastic Surgery device
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Aug 1984
Decision
165d
Days
Class 2
Risk

K840946 is an FDA 510(k) clearance for the MICROPOROUS HYPOALLERGENIC. Classified as Ring (wound Protector), Drape Retention, Internal (product code KGW), Class II - Special Controls.

Submitted by Gainor Medical. The FDA issued a Cleared decision on August 17, 1984 after a review of 165 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery device framework. 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 Gainor Medical devices

Submission Details

510(k) Number K840946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1984
Decision Date August 17, 1984
Days to Decision 165 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
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGW Ring (wound Protector), Drape Retention, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KGW Ring (wound Protector), Drape Retention, Internal

All 8
Devices cleared under the same product code (KGW) and FDA review panel - the closest regulatory comparables to K840946.
ALEXIS LAPAROSCOPIC SYSTEM
K093296 · Applied Medical Resources Corp. · Nov 2009
ALEXIS WOUND RETRACTOR
K062907 · Applied Medical Resources · Jan 2007
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
K041711 · Applied Medical Resources Corp. · Aug 2004
EDGE PROTECTOR, BARRIER
K790306 · Surgikos, Inc. · Feb 1979