Cleared Traditional

K813124 - ETHICON* SKIN CLOSURE TAPE

K813124 is an FDA 510(k) clearance for ETHICON* SKIN CLOSURE TAPE, manufactured by Ethicon, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K813124 · Ethicon, Inc. · General & Plastic Surgery device
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Dec 1981
Decision
34d
Days
Class 1
Risk

K813124 is an FDA 510(k) clearance for the ETHICON* SKIN CLOSURE TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on December 8, 1981 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K813124

510(k) Number K813124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1981
Decision Date December 08, 1981
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 89
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K813124.
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K813265 · 3M Company · Feb 1983
CURITY SHETHOSCOPE SECURING PADS
K820872 · The Kendal Co. · Apr 1982
NON-ADHER PADS
K813421 · Abco Dealers, Inc. · Dec 1981
DESERET CATHETER DRESSING
K812073 · Warner-Lambert Co. · Oct 1981
TEGADERM TRANSPARENT DRESSING
K811291 · 3M Company · Jun 1981
VECAFIX*
K810050 · Pollak (Intl.), Ltd. · Mar 1981