KOXClass I
Solvent, Adhesive Tape
21 CFR 878.4730 / General, Plastic Surgery
KOX is the FDA product code for Solvent, Adhesive Tape, a class I device type, regulated under 21 CFR 878.4730. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- KOX
- Device name
- Solvent, Adhesive Tape
- Regulation
- 21 CFR 878.4730
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 12
- Ingested recalls
- 3
Clearances, product code KOX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1992 | 2 |
| 1993 | 4 |
| 1994 | 1 |
Applicants with the most clearances
Product code KOX| Applicant | Clearances |
|---|---|
| Smith & Nephew United, Inc. | 2 |
| 3M Company | 1 |
| Chad Labs Corp. | 1 |
| MEDLINE INDUSTRIES, LP - Northfield | 1 |
| Convatec, A Division of E.R. Squibb & Sons | 1 |
| Elantec, Inc. | 1 |
| Kemi Labs, Inc. | 1 |
| Medi-Flex Hospital Products, Inc. | 1 |
| Orange-Sol, Inc. | 1 |
| Stephens Scientific | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
