Cleared Traditional

K941943 - SURGICAL ADHESIVE TAPE

K941943 is an FDA 510(k) clearance for SURGICAL ADHESIVE TAPE, manufactured by Raleigh Lions Clinic For the Blind, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K941943 · Raleigh Lions Clinic For the Blind, Inc. · General & Plastic Surgery device
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Jun 1994
Decision
70d
Days
Class 1
Risk

K941943 is an FDA 510(k) clearance for the SURGICAL ADHESIVE TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Raleigh Lions Clinic For the Blind, Inc. (Raleigh, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 70 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 Raleigh Lions Clinic For the Blind, Inc. devices

FDA 510(k) Submission Details - K941943

510(k) Number K941943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1994
Decision Date June 30, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
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 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K941943.
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
EMPI TAPE PATCHES
K941389 · Empi · Aug 1994
COVERLET ADHESIVE DRESSING
K940378 · Beiersdorf, Inc. · Jul 1994
CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM
K935948 · Convatec, A Division of E.R. Squibb & Sons · Mar 1994
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
K935725 · Deroyal Industries, Inc. · Feb 1994
3M TEGADERM HP TRANSPARENT DRESSING
K932422 · 3M Health Care, Ltd. · Dec 1993