GXB · Esthesiometer
Neurology · 21 CFR 882.1500 · Class 1
Overview
| Product Code | GXB |
|---|---|
| Device Name | Esthesiometer |
| Regulation | 21 CFR 882.1500 |
| Device Class | Class 1 |
| Review Panel | Neurology |
| GMP Exempt | Yes |
Identification
An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143068 | Medical Monofilament Sensory Screening Toool | Medical Monofilament Manufacturing | Jan 14, 2015 | SESE |
| K933798 | NU-PREP GEL | Cadwell Laboratories, Inc. | Apr 22, 1994 | SESE |
| K871571 | NEUROTIPS(TM) | Ulster Scientific, Inc. | Jun 18, 1987 | SESE |
| K801907 | ALGESIOMETER | Rowan Products, Inc. | Sep 16, 1980 | SESE |
| K772406 | AESTHESIOMETER | Fred Sammons, Inc. | Jan 6, 1978 | SESE |
| K771847 | TEMP-TESTER | Jablecki, Charles, Dr. | Nov 2, 1977 | SESE |
| K761133 | AESTHESIOMETER | Fred Sammons, Inc. | Dec 2, 1976 | SESE |
Top Applicants
- Fred Sammons, Inc. — 2 clearances
- Cadwell Laboratories, Inc. — 1 clearance
- Jablecki, Charles, Dr. — 1 clearance
- Medical Monofilament Manufacturing — 1 clearance
- Rowan Products, Inc. — 1 clearance
