GWZ · Percussor
Neurology · 21 CFR 882.1700 · Class 1
Overview
| Product Code | GWZ |
|---|---|
| Device Name | Percussor |
| Regulation | 21 CFR 882.1700 |
| Device Class | Class 1 |
| Review Panel | Neurology |
| GMP Exempt | Yes |
Identification
A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations.
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 the limitations in § 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.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891571 | PERCUSSION HAMMER | Sandal Surgico | Mar 31, 1989 | SESE |
| K852716 | TAYLOR PERCUSSION HAMMER SS 410 OR 420 | The Huxley Instrument Corp. | Jul 26, 1985 | SESE |
| K851748 | 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE | Artiberia | Jun 13, 1985 | SESE |
| K840314 | CAT 10-NEUROLOGY DEVICE | Imm Enterprises , Ltd. | Feb 23, 1984 | SESE |
| K834178 | H.R. JAKOBI SURG. INSTR. #10 34/36 | Imm Enterprises , Ltd. | Feb 23, 1984 | SESE |
| K834170 | OP-CON SURG. INSTRUMENT #10 | Imm Enterprises , Ltd. | Feb 23, 1984 | SESE |
| K810054 | RICA (DIAGNOSTIC INSTRUMENTS) | Robert I. Chien & Assoc., Inc. | Jan 28, 1981 | SESE |
| K803148 | CONPHAR PERCUSSION HAMMER(TAYLOR) | Conphar, Inc. | Jan 8, 1981 | SESE |
| K803174 | CONPHAR PERCUSSION HAMMER(BUCK TYPE) | Conphar, Inc. | Dec 30, 1980 | SESE |
| K791337 | TAYLOR NEUROLOGICAL HAMMER | Amdia Medical Products | Aug 3, 1979 | SESE |
| K791336 | BUCKS NEUROLOGICAL HAMMER | Amdia Medical Products | Aug 3, 1979 | SESE |
Top Applicants
- Imm Enterprises , Ltd. — 3 clearances
- Conphar, Inc. — 2 clearances
- Amdia Medical Products — 2 clearances
- The Huxley Instrument Corp. — 1 clearance
- Sandal Surgico — 1 clearance
