Cleared Traditional

K882558 - AREOLA/NIPPLE DRESSING

K882558 is an FDA 510(k) clearance for AREOLA/NIPPLE DRESSING, manufactured by Cooper Surgical/Aesthete. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K882558 · Cooper Surgical/Aesthete · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
337d
Days
Class 1
Risk

K882558 is an FDA 510(k) clearance for the AREOLA/NIPPLE DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Cooper Surgical/Aesthete (Paso Robles, US). The FDA issued a Cleared decision on May 24, 1989 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Cooper Surgical/Aesthete devices

FDA 510(k) Submission Details - K882558

510(k) Number K882558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date May 24, 1989
Days to Decision 337 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 115d · This submission: 337d
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 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K882558.
TENSOPLUS LITE
K901378 · Smith & Nephew United, Inc. · Jun 1990
2018 ARTERIAL/VENOUS PRESSURE DRESSING
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HYPAFIX DRESSING RETENTION SHEET
K894254 · Smith & Nephew United, Inc. · Aug 1989
DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
K892527 · Convatec, A Division of E.R. Squibb & Sons · May 1989
DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING
K891696 · Convatec, A Division of E.R. Squibb & Sons · May 1989
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · 3M Company · Apr 1989