Cleared Traditional

K872875 - STRETCH GAUZE BANDAGES

K872875 is an FDA 510(k) clearance for STRETCH GAUZE BANDAGES, manufactured by Abco Dealers, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K872875 · Abco Dealers, Inc. · General & Plastic Surgery device
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Sep 1987
Decision
45d
Days
Class 1
Risk

K872875 is an FDA 510(k) clearance for the STRETCH GAUZE BANDAGES. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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.

FDA 510(k) Submission Details - K872875

510(k) Number K872875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1987
Decision Date September 04, 1987
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 107
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K872875.
EPI-LOCK T.M. PRIMADERM
K874291 · Derma-Lock Medical Corp. · Nov 1987
MITRAFLEX(TM) WOUND DRESSING
K873277 · Matrix Medica, Inc. · Sep 1987
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · Smith & Nephew, Inc. · Sep 1987
JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING
K872982 · Johnson & Johnson Professionals, Inc. · Aug 1987
KONTOUR ULTRA SOFT SPONGE #SS144.50
K872069 · Winfield Laboratories, Inc. · Jul 1987
BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS.
K872099 · The Bfgoodrich Co. · Jun 1987
K872875 · STRETCH GAUZE BANDAGES
Download PDF Abco Dealers, Inc.