Product code GXB
- Device name
- Esthesiometer
- Medical specialty
- Neurology
- Device class
- 1
- Regulation number
- 882.1500
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143068 | Medical Monofilament Sensory Screening Toool | Medical Monofilament Manufacturing | 2015-01-14 |
| K933798 | NU-PREP GEL | Cadwell Laboratories, Inc. | 1994-04-22 |
| K871571 | NEUROTIPS(TM) | Ulster Scientific, Inc. | 1987-06-18 |
| K801907 | ALGESIOMETER | Rowan Products, Inc. | 1980-09-16 |
| K772406 | AESTHESIOMETER | Fred Sammons, Inc. | 1978-01-06 |
| K771847 | TEMP-TESTER | Jablecki, Charles, Dr. | 1977-11-02 |
| K761133 | AESTHESIOMETER | Fred Sammons, Inc. | 1976-12-02 |
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| 00609271039803 | DARCO® Monofilament Tester | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000094 | DARCO® Foot Filament | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 10609271039800 | DARCO® Monofilament Tester | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 04262355230570 | The PINPRICK | MRC SYSTEMS GmbH Medizintechnische Systeme | 2022-12-07 |
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