KXFClass I
Applicator, Absorbent Tipped, Non-Sterile
21 CFR 880.6025 / General Hospital
KXF is the FDA product code for Applicator, Absorbent Tipped, Non-Sterile, a class I device type, regulated under 21 CFR 880.6025. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- KXF
- Device name
- Applicator, Absorbent Tipped, Non-Sterile
- Regulation
- 21 CFR 880.6025
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 21
- Ingested recalls
- 2
Clearances, product code KXF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 3 |
| 1979 | 2 |
| 1980 | 3 |
| 1981 | 1 |
| 1982 | 2 |
| 1984 | 1 |
| 1987 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code KXF| Applicant | Clearances |
|---|---|
| Smartpractice | 3 |
| Abco Dealers, Inc. | 2 |
| Dexide, Inc. | 2 |
| Pollak (Intl.).ltd | 2 |
| American Hospital Supply | 1 |
| American Pharmaseal Div. Ahsc | 1 |
| Brell Mar Products, Inc. | 1 |
| Chesebrough-Pond'S U.S.A. Co. | 1 |
| Dafoe & Dafoe, Inc. | 1 |
| Dormer Laboratories, Inc. | 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.