Cleared Traditional

K872988 - TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING

K872988 is an FDA 510(k) clearance for TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING, manufactured by Smith & Nephew, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K872988 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Sep 1987
Decision
47d
Days
Class 1
Risk

K872988 is an FDA 510(k) clearance for the TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on September 16, 1987 after a review of 47 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 - K872988

510(k) Number K872988 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 31, 1987
Decision Date September 16, 1987
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
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 K872988.
MODIFIED USE OF TRIANGLE BANDAGE STERILE
K874161 · K. W. Griffen Co. · Dec 1987
EPI-LOCK T.M. PRIMADERM
K874291 · Derma-Lock Medical Corp. · Nov 1987
MITRAFLEX(TM) WOUND DRESSING
K873277 · Matrix Medica, Inc. · Sep 1987
STRETCH GAUZE BANDAGES
K872875 · Abco Dealers, 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
K872988 · TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
Download PDF Smith & Nephew, Inc.