Remove Adhesive Remover
FDA 510(k) K893603 · Smith & Nephew United, Inc.
510(k) numberK893603
Submission
- Device name
- Remove Adhesive Remover
- Applicant
- Smith & Nephew United, Inc.
Largo, FL, US - Received
- May 16, 1989
- Decision date
- July 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOX – Solvent, Adhesive Tape
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4730
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934790 | Sepp Adhesive RemoverKOX · Traditional | Medi-Flex Hospital Products, Inc. | 03/11/1994SE |
| K931933 | Chad Labs Adhesive Bandage RemoverKOX · Traditional | Chad Labs Corp. | 07/08/1993SE |
| K924976 | Allkare(Tm) Adhesive Remover WipeKOX · Traditional | Convatec, A Division of E.R. Squibb & Sons | 04/20/1993SE |
| K924571 | Medi-SolKOX · Traditional | Orange-Sol, Inc. | 04/06/1993SE |
| K925618 | 3M Remover Lotion Product Number 86XXKOX · Traditional | 3M Health Care, Ltd. | 03/31/1993SE |
| K923351 | Skin Support Prep PadKOX · Traditional | Coloplast Corp. | 09/14/1992SE |
| K915150 | Remove Adhesive RemoverKOX · Traditional | Smith & Nephew United, Inc. | 01/09/1992SE |
| K902009 | Elantec's Surgical Tape RemoverKOX · Traditional | Elantec, Inc. | 08/29/1990SE |
| K895293 | Kemi Labs - Adhesive Bandage RemoverKOX · Traditional | Kemi Labs, Inc. | 02/09/1990SE |
| K881359 | Decalcifying Solution IIKOX · Traditional | Stephens Scientific | 04/19/1988SE |
More from Stephens Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K963096 | Allevyn Hydro Poly Dressing ND All Trac DressingKMF · Traditional | 10/25/1996SE |
| K961775 | Profore Four-Layer Bandage System KitEFQ · Traditional | 07/16/1996SE |
| K945330 | Allevyn AdhesiveKMF · Traditional | 02/09/1995SN |
| K943619 | Cavi-Care Conforming Foam DressingKMF · Traditional | 08/19/1994SN |
| K942748 | IntrasiteNAE · Traditional | 06/29/1994SN |
| K935705 | Allevyn Island Wound DressingNAE · Traditional | 02/15/1994SE |
| K935803 | Cica-Care Silicone Gel SheetMDA · Traditional | 02/03/1994SE |
| K932263 | Solosite Dermal Wound GelMGQ · Traditional | 10/01/1993SE |
| K926508 | Intrasite GelNAE · Traditional | 07/13/1993SE |
| K922897 | StrappalKGX · Traditional | 09/15/1992SE |
Questions and answers
When was Remove Adhesive Remover cleared by the FDA?
Remove Adhesive Remover (K893603) received a 510(k) decision of Substantially Equivalent on July 14, 1989, 59 days after the submission was received.
What is the product code of K893603?
The FDA product code is KOX – Solvent, Adhesive Tape, a Class I (low risk) device regulated under 21 CFR 878.4730.