GXB
7 FDA 510(k) clearances · Product code
36 daysmedian time to decision
261 days90th percentile
7clearances measured
FDA profile
- Official device name
- Esthesiometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 882.1500
- Medical specialty
- Neurology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Medical Monofilament Sensory Screening Toool (K143068) | Medical Monofilament Manufacturing | 2015-01-14 |
| NU-PREP GEL (K933798) | Cadwell Laboratories, Inc. | 1994-04-22 |
| NEUROTIPS(TM) (K871571) | Ulster Scientific, Inc. | 1987-06-18 |
| ALGESIOMETER (K801907) | Rowan Products, Inc. | 1980-09-16 |
| AESTHESIOMETER (K772406) | Fred Sammons, Inc. | 1978-01-06 |
| TEMP-TESTER (K771847) | Jablecki, Charles, Dr. | 1977-11-02 |
| AESTHESIOMETER (K761133) | Fred Sammons, Inc. | 1976-12-02 |
Track GXB automatically
Every clearance here is in the API, with alerts when new ones post.