Cleared Traditional

K830166 - MOLNLYCKE ETE STERILE NON-ADHERENT DRESS

K830166 is an FDA 510(k) clearance for MOLNLYCKE ETE STERILE NON-ADHERENT DRESS, manufactured by Lada Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K830166 · Lada Intl., Inc. · General & Plastic Surgery device
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Feb 1983
Decision
22d
Days
Class 1
Risk

K830166 is an FDA 510(k) clearance for the MOLNLYCKE ETE STERILE NON-ADHERENT DRESS. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Lada Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1983 after a review of 22 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 Lada Intl., Inc. devices

FDA 510(k) Submission Details - K830166

510(k) Number K830166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1983
Decision Date February 09, 1983
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 34
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K830166.
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
NOVA GAUZE
K830473 · American Threshold Industries, Inc. · Apr 1983
COVER-ROLL STRETCH
K823879 · Beiersdorf, Inc. · Mar 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