FDA product code GXB: Esthesiometer
GXB is the FDA product code for esthesiometer. It is a Class I device, regulated under 21 CFR 882.1500 and reviewed by the Neurology panel. FDA has cleared 7 510(k) submissions under GXB, from 6 different applicants. The average 510(k) review took 71 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Esthesiometer |
| Device class | Class I |
| Regulation | 21 CFR 882.1500 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top GXB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 2 | 1978-01-06 |
| Medical Monofilament Manufacturing | 1 | 2015-01-14 |
| Cadwell Laboratories, Inc. | 1 | 1994-04-22 |
| Ulster Scientific, Inc. | 1 | 1987-06-18 |
| Rowan Products, Inc. | 1 | 1980-09-16 |
1 more applicants have GXB clearances. See the full list in Caduvo.
Most recent GXB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143068 | Medical Monofilament Manufacturing | Medical Monofilament Sensory Screening Toool | 2015-01-14 | 82 |
| K933798 | Cadwell Laboratories, Inc. | NU-PREP GEL | 1994-04-22 | 261 |
| K871571 | Ulster Scientific, Inc. | NEUROTIPS(TM) | 1987-06-18 | 57 |
| K801907 | Rowan Products, Inc. | ALGESIOMETER | 1980-09-16 | 36 |
| K772406 | Fred Sammons, Inc. | AESTHESIOMETER | 1978-01-06 | 10 |
Recalls for GXB devices
openFDA lists no recalls for product code GXB.
Frequently asked questions
What is FDA product code GXB?
GXB is the FDA product code for esthesiometer. It is a Class I device, regulated under 21 CFR 882.1500 and reviewed by the Neurology panel.
What device class is GXB?
Class I, regulation 21 CFR 882.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GXB?
Across 7 cleared submissions the average was 71 days from receipt to decision (median 36).
Which companies have the most GXB clearances?
Fred Sammons, Inc. (2); Medical Monofilament Manufacturing (1); Cadwell Laboratories, Inc. (1); Ulster Scientific, Inc. (1); Rowan Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GXB
- Run a recall and safety report across every GXB manufacturer
- Watch product code GXB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.