Esthesiometer
The Esthesiometer is a neurological diagnostic instrument used to assess sensory perception, particularly the ability to detect touch, pressure, or pain stimuli on the skin or mucous membranes. It is classified as a Class 1 device (lowest risk), subject only to general controls, and is GMP exempt, meaning it is not required to comply with current Good Manufacturing Practice regulations. The product code is GXB under regulation 21 CFR 882.1500, falling within the Neurology medical specialty. No implant, life-sustaining, or third-party review flags apply.
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Basic Information
- Product Code
- GXB
- Device Class
- FDA class 1
- Regulation Number
- 882.1500
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K143068 | Medical Monofilament Sensory Screening Toool | Jan 14, 2015 | Substantially Equivalent | Medical Monofilament Manufacturing |
| K933798 | NU-PREP GEL | Apr 22, 1994 | Substantially Equivalent | Cadwell Laboratories, Inc. |
| K871571 | NEUROTIPS(TM) | Jun 18, 1987 | Substantially Equivalent | Ulster Scientific, Inc. |
| K801907 | ALGESIOMETER | Sep 16, 1980 | Substantially Equivalent | Rowan Products, Inc. |
| K772406 | AESTHESIOMETER | Jan 06, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K771847 | TEMP-TESTER | Nov 02, 1977 | Substantially Equivalent | Jablecki, Charles, Dr. |
| K761133 | AESTHESIOMETER | Dec 02, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.