Cleared Traditional

K946015 - IVALON EXTERNAL SPONGE

K946015 is an FDA 510(k) clearance for IVALON EXTERNAL SPONGE, manufactured by Ivalon. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 80-day FDA review.

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

FDA 510(k) Submission Details - K946015

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.

NAB Device Classification - Class 1, General Controls

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 34
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K946015.
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
K920282 · Trinity Laboratories, Inc. · May 1992
ABSORBENT FIBER
K914431 · Ulti-Med Intl., Inc. · Dec 1991
CONFORMING BANDAGE
K912692 · Ulti-Med Intl., Inc. · Oct 1991
POST OPERATIVE SPONGE
K912693 · Ulti-Med Intl., Inc. · Oct 1991
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
K891101 · Smith & Nephew United, Inc. · Apr 1989
ABSORBENT GAUZE ROLL
K890672 · Smith & Nephew United, Inc. · Apr 1989