GXB — Esthesiometer Class I
FDA product code GXB covers "Esthesiometer", a Class I medical device regulated under 21 CFR 882.1500. Submissions are reviewed by the Neurology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXB
- Device Class
- Class I
- Regulation Number
- 882.1500
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143068 | Medical Monofilament Manufacturing | Medical Monofilament Sensory Screening Toool | Jan 14, 2015 |
| K933798 | Cadwell Laboratories | NU-PREP GEL | Apr 22, 1994 |
| K871571 | Ulster Scientific | NEUROTIPS(TM) | Jun 18, 1987 |
| K801907 | Rowan Products | ALGESIOMETER | Sep 16, 1980 |
| K772406 | Fred Sammons | AESTHESIOMETER | Jan 6, 1978 |
| K771847 | Jablecki, Charles, Dr | TEMP-TESTER | Nov 2, 1977 |
| K761133 | Fred Sammons | AESTHESIOMETER | Dec 2, 1976 |