Cleared Traditional

K896891 - LEUKOSILK(TM) SURGICAL TAPE

K896891 is an FDA 510(k) clearance for LEUKOSILK(TM) SURGICAL TAPE, manufactured by Beiersdorf, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K896891 · Beiersdorf, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
63d
Days
Class 1
Risk

K896891 is an FDA 510(k) clearance for the LEUKOSILK(TM) SURGICAL TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 63 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K896891

510(k) Number K896891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date February 09, 1990
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 77
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K896891.
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
K901879 · Smith & Nephew United, Inc. · Jun 1990
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
K902010 · Visitec Co. · Jun 1990
DUODERM* ADHESIVE COMPRESSION BANDAGE
K900447 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)
K895408 · Smith & Nephew United, Inc. · Dec 1989
LEUKOSPORT(TM) ADHESIVE TAPE
K894367 · Beiersdorf, Inc. · Nov 1989
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · Quinton, Inc. · Oct 1989