Tipstop(Tm)

FDA 510(k) K896068 · Gambro-Hospal, Inc.

Substantially Equivalent

510(k) numberK896068

Submission

Device name
Tipstop(Tm)
Applicant
Gambro-Hospal, Inc.
Williamsburg, VA, US
Received
October 19, 1989
Decision date
September 10, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KGX – Tape And Bandage, Adhesive
Device class
Class I (low risk)
Regulation
21 CFR 880.5240
Specialty
General Hospital

Other 510(k)s with product code KGX

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K001240Seragard Injection PatchKGX · Traditional Platinum Services, Inc.06/21/2000SE
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K972914Syvek PatchKGX · Traditional Marine Polymer Technologies, Inc.12/22/1997SE
K943314Adhesive Bandages with OTC DrugKGX · Traditional Johnson & Johnson Consumer Products, Inc.01/17/1996SE
K952606Targett PatchKGX · Traditional Cutting Edge Technologies, Inc.12/21/1995SE
K954007ParallelKGX · Traditional Johnson & Johnson Consumer Products, Inc.11/22/1995SE
K944587Dermiview Hypoallergenic Clear TapeKGX · Traditional Johnson & Johnson Medical, Inc.10/30/1995SE
K944588Sterile Plastic DressingKGX · Traditional Smith & Nephew, Inc.11/07/1994SE
K941788Band-Aid Brand Adhesive Bandages, Sport StripKGX · Traditional Johnson & Johnson Consumer Products, Inc.10/03/1994SE
K940536Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional Johnson & Johnson Consumer Products, Inc.10/03/1994SE

More from Johnson & Johnson Consumer Products, Inc.

510(k)DeviceDecision
K902588BSM/21&22 SC Blood Safe Mod & V.P.M. Ven Press ModKOC · Traditional 03/07/1991SE
K901368Hemospal Kits A1, A2D, Ao, & A1DFJG · Traditional 08/02/1990SE

Questions and answers

When was Tipstop(Tm) cleared by the FDA?

Tipstop(Tm) (K896068) received a 510(k) decision of Substantially Equivalent on September 10, 1990, 326 days after the submission was received.

What is the product code of K896068?

The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.