Cleared Traditional

K821246 - MELOLIN

K821246 is the FDA 510(k) clearance for MELOLIN by Smith & Nephew, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K821246 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Aug 1982
Decision
99d
Days
Class 1
Risk

K821246 is an FDA 510(k) clearance for the MELOLIN. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 6, 1982 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K821246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1982
Decision Date August 06, 1982
Days to Decision 99 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
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 18
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K821246.
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
COVER-ROLL STRETCH
K823879 · Beiersdorf, Inc. · Mar 1983
CONVERTORS DISPOSABLE DRESSING SPONGE
K822966 · American Hospital Supply Corp. · Nov 1982
INTERSORB DRY BURN VEST & PANTS
K822047 · Chesebrough-Pond'S U.S.A. Co. · Jul 1982
UNIFLEX
K820470 · Howmedica Corp. · Jun 1982
HOLLISTER ODOR ABSORBING WOUND PAD
K820464 · Hollister, Inc. · Mar 1982