Cleared Traditional

K823879 - COVER-ROLL STRETCH

K823879 is an FDA 510(k) clearance for COVER-ROLL STRETCH, manufactured by Beiersdorf, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K823879 · Beiersdorf, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
72d
Days
Class 1
Risk

K823879 is an FDA 510(k) clearance for the COVER-ROLL STRETCH. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Beiersdorf, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K823879

510(k) Number K823879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date March 09, 1983
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 19
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K823879.
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
AN ODOR ABSORBENT BANDAGE
K833735 · American Medical Disposable, Inc. · Apr 1984
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
CONVERTORS DISPOSABLE DRESSING SPONGE
K822966 · American Hospital Supply Corp. · Nov 1982
MELOLIN
K821246 · Smith & Nephew, Inc. · Aug 1982
INTERSORB DRY BURN VEST & PANTS
K822047 · Chesebrough-Pond'S U.S.A. Co. · Jul 1982