Cleared Traditional

IVALON EXTERNAL SPONGE (K946015) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K946015 · Ivalon · General & Plastic Surgery device
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Feb 1995
Decision
80d
Days
Class 1
Risk

K946015 is an FDA 510(k) clearance for the IVALON EXTERNAL SPONGE. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Ivalon (San Diego, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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: 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 Ivalon devices

Submission Details

510(k) Number K946015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date February 27, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAB Gauze / Sponge,nonresorbable For External Use

All 87
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K946015.
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
MELOLIN
K821246 · Smith & Nephew, Inc. · Aug 1982
UNIFLEX
K820470 · Howmedica Corp. · Jun 1982
BONE-DRI SURGICAL SPONGE
K803125 · Howmedica Corp. · Jan 1981
BANDAGE COMPRESS 2, 3, 4
K770410 · Johnson & Johnson Professionals, Inc. · Jun 1977