KGXClass I
Tape And Bandage, Adhesive
21 CFR 880.5240 / General Hospital
KGX is the FDA product code for Tape And Bandage, Adhesive, a class I device type, regulated under 21 CFR 880.5240. As of , FDA records hold 187 510(k) clearances under this code, the most recent dated , and 48 recalls.
Classification record
- Product code
- KGX
- Device name
- Tape And Bandage, Adhesive
- Regulation
- 21 CFR 880.5240
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 187
- Ingested recalls
- 48
Clearances, product code KGX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1979 | 5 |
| 1980 | 9 |
| 1981 | 11 |
| 1982 | 6 |
| 1983 | 5 |
| 1984 | 19 |
| 1985 | 15 |
| 1986 | 4 |
| 1987 | 10 |
| 1988 | 6 |
| 1989 | 14 |
| 1990 | 11 |
| 1991 | 16 |
| 1992 | 18 |
| 1993 | 14 |
| 1994 | 14 |
| 1995 | 3 |
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 1 |
Applicants with the most clearances
Product code KGX| Applicant | Clearances |
|---|---|
| Beiersdorf, Inc. | 15 |
| Lectec Corp. | 8 |
| Avery Intl. | 6 |
| Convatec, A Division of E.R. Squibb & Sons | 6 |
| Johnson & Johnson Professionals, Inc. | 6 |
| Smith & Nephew United, Inc. | 6 |
| Abco Dealers, Inc. | 4 |
| Gainor Medical | 4 |
| Johnson & Johnson Consumer Products, Inc. | 4 |
| Nitto Denko America, Inc. | 4 |
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.
