Cleared Traditional

K896068 - TIPSTOP(TM)

K896068 is an FDA 510(k) clearance for TIPSTOP(TM), manufactured by Gambro-Hospal, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K896068 · Gambro-Hospal, Inc. · General & Plastic Surgery device
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Sep 1990
Decision
326d
Days
Class 1
Risk

K896068 is an FDA 510(k) clearance for the TIPSTOP(TM). Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Gambro-Hospal, Inc. (Williamsburg, US). The FDA issued a Cleared decision on September 10, 1990 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Gambro-Hospal, Inc. devices

FDA 510(k) Submission Details - K896068

510(k) Number K896068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date September 10, 1990
Days to Decision 326 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
211d slower than avg
Panel avg: 115d · This submission: 326d
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 84
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K896068.
TRO-GARD
K910678 · Conmedcorp · May 1991
ELASTIC ADHESIVE BANDAGE
K910436 · Byron Medical · Mar 1991
ELASTOPLAST
K904500 · Beiersdorf, Inc. · Nov 1990
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
K901879 · Smith & Nephew United, Inc. · Jun 1990