Solvent, Adhesive Tape
This device is a solvent used to remove adhesive tape from skin or medical surfaces in a surgical or wound care context. It is classified as FDA Class 1, reflecting low risk and requiring only general controls such as appropriate labeling. The product code is KOX, regulated under 21 CFR 878.4730 within the General and Plastic Surgery specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KOX
- Device Class
- FDA class 1
- Regulation Number
- 878.4730
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934790 | SEPP ADHESIVE REMOVER | Mar 11, 1994 | Substantially Equivalent | Medi-Flex Hospital Products, Inc. |
| K931933 | CHAD LABS ADHESIVE BANDAGE REMOVER | Jul 08, 1993 | Substantially Equivalent | Chad Labs Corp. |
| K924976 | ALLKARE(TM) ADHESIVE REMOVER WIPE | Apr 20, 1993 | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons |
| K924571 | MEDI-SOL | Apr 06, 1993 | Substantially Equivalent | Orange-Sol, Inc. |
| K925618 | 3M REMOVER LOTION PRODUCT NUMBER 86XX | Mar 31, 1993 | Substantially Equivalent | 3M Health Care, Ltd. |
| K923351 | SKIN SUPPORT PREP PAD | Sep 14, 1992 | Substantially Equivalent | Coloplast Corp. |
| K915150 | REMOVE ADHESIVE REMOVER | Jan 09, 1992 | Substantially Equivalent | Smith & Nephew United, Inc. |
| K902009 | ELANTEC'S SURGICAL TAPE REMOVER | Aug 29, 1990 | Substantially Equivalent | Elantec, Inc. |
| K895293 | KEMI LABS - ADHESIVE BANDAGE REMOVER | Feb 09, 1990 | Substantially Equivalent | Kemi Labs, Inc. |
| K893603 | REMOVE ADHESIVE REMOVER | Jul 14, 1989 | Substantially Equivalent | Smith & Nephew United, Inc. |
| K881359 | DECALCIFYING SOLUTION II | Apr 19, 1988 | Substantially Equivalent | Stephens Scientific |
| K821162 | ADHESIVE REMOVER | May 14, 1982 | Substantially Equivalent | The Healthcare Group Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 102 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 102 registration numbers. Click on an entry to view related FDA registrations.