GXBClass I
Esthesiometer
21 CFR 882.1500 / Neurology
GXB is the FDA product code for Esthesiometer, a class I device type, regulated under 21 CFR 882.1500. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- GXB
- Device name
- Esthesiometer
- Regulation
- 21 CFR 882.1500
- Device class
- Class I
- Review panel
- Neurology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code GXB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1978 | 1 |
| 1980 | 1 |
| 1987 | 1 |
| 1994 | 1 |
| 2015 | 1 |
Applicants with the most clearances
Product code GXB| Applicant | Clearances |
|---|---|
| Fred Sammons, Inc. | 2 |
| Cadwell Laboratories, Inc. | 1 |
| Jablecki, Charles, Dr. | 1 |
| Medical Monofilament Manufacturing | 1 |
| Rowan Products, Inc. | 1 |
| Ulster Scientific, 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.