GZX · Instrument, Microsurgical
Neurology · 21 CFR 882.4525 · Class 1
Overview
| Product Code | GZX |
|---|---|
| Device Name | Instrument, Microsurgical |
| Regulation | 21 CFR 882.4525 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.
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.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932169 | MICROSURGICAL INSTRUMENTS | American Russian Medical Services, Inc. | Jul 20, 1993 | SESE |
| K926048 | CLARUS ENDOSCOPIC BALL PROBE | Clarus Medical Systems, Inc. | Apr 7, 1993 | SESE |
| K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK | O.R. Specialties, Inc. | Aug 26, 1991 | SESE |
| K890216 | MICROSURGICAL KERATOME | Kinetic Medical Products | Feb 16, 1989 | SESE |
| K873934 | RANGE OF CROCODILE ACTION INSTRUMENTS | Downs Surgical , Ltd. | Dec 17, 1987 | SESE |
| K873933 | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM | Downs Surgical , Ltd. | Dec 17, 1987 | SESE |
| K862971 | MICRA MICROSURGICAL INSTRUMENTS | Cordis Corp. | Aug 25, 1986 | SESE |
| K853179 | VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND | Keeler Instruments, Inc. | Nov 7, 1985 | SESE |
| K853161 | THE VICKERS STANDARD MICROSURGERY SET | Keeler Instruments, Inc. | Nov 7, 1985 | SESE |
| K853181 | VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED | Keeler Instruments, Inc. | Oct 28, 1985 | SESE |
| K853180 | VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED | Keeler Instruments, Inc. | Oct 28, 1985 | SESE |
| K831071 | UNIVERSAL INSTRU. SET FOR NEUROVASCULAR | Prothia USA, Inc. | Jun 8, 1983 | SESE |
| K810485 | DUJOVNY MICROSURGICAL SCISSORS | American V. Mueller | Feb 27, 1981 | SESE |
Top Applicants
- Keeler Instruments, Inc. — 4 clearances
- Downs Surgical , Ltd. — 2 clearances
- Prothia USA, Inc. — 1 clearance
- O.R. Specialties, Inc. — 1 clearance
- Kinetic Medical Products — 1 clearance
