Cleared Traditional

K833735 - AN ODOR ABSORBENT BANDAGE

K833735 is an FDA 510(k) clearance for AN ODOR ABSORBENT BANDAGE, manufactured by American Medical Disposable, Inc.. The device is a Class 1 General & Plastic Surgery device with 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
Download Printable Device Report (PDF)
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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.

FDA 510(k) Submission Details - K833735

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.

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 87
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K833735.
4 X 4 SPONGES, NON-STERILE
K870282 · The Medical Group, Inc. · Feb 1987
3 X 3 SPONGES, NON-STERILE
K870283 · The Medical Group, Inc. · Feb 1987
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
PDI SURGICAL SCRUB/BRUSH T150-70
K833549 · Nice-Pak Products, Inc. · Nov 1983
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
GAUZE COMPRESS
K831281 · Pac-Kit Safety Equipment Co. · Aug 1983
K833735 · AN ODOR ABSORBENT BANDAGE
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