Medical Monofilament Sensory Screening Toool
FDA 510(k) clearance K143068 · decided 2015-01-14
Clearance details
- K-number
- K143068
- Device name
- Medical Monofilament Sensory Screening Toool
- Applicant
- Medical Monofilament Manufacturing
- Decision
- Substantially Equivalent
- Date received
- 2014-10-24
- Decision date
- 2015-01-14
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- GXB
- Device class
- 1
- Regulation number
- 882.1500
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plymouth, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.