Cleared Traditional

K833735 - AN ODOR ABSORBENT BANDAGE

K833735 is the FDA 510(k) clearance for AN ODOR ABSORBENT BANDAGE by American Medical Disposable, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K833735 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
181d
Days
Class 1
Risk

K833735 is an FDA 510(k) clearance for the AN ODOR ABSORBENT BANDAGE. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by American Medical Disposable, Inc. (Walker, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 181 days - an extended review 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: 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 American Medical Disposable, Inc. devices

Submission Details

510(k) Number K833735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1983
Decision Date April 23, 1984
Days to Decision 181 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 115d · This submission: 181d
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 18
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K833735.
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
K891101 · Smith & Nephew United, Inc. · Apr 1989
ABSORBENT GAUZE ROLL
K890672 · Smith & Nephew United, Inc. · Apr 1989
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
COVER-ROLL STRETCH
K823879 · Beiersdorf, Inc. · Mar 1983
CONVERTORS DISPOSABLE DRESSING SPONGE
K822966 · American Hospital Supply Corp. · Nov 1982