Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4525](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4525) → GZX — Instrument, Microsurgical

# GZX · Instrument, Microsurgical

_Neurology · 21 CFR 882.4525 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX

## Overview

- **Product Code:** GZX
- **Device Name:** Instrument, Microsurgical
- **Regulation:** [21 CFR 882.4525](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4525)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K932169.md) | MICROSURGICAL INSTRUMENTS | American Russian Medical Services, Inc. | Jul 20, 1993 | SESE |
| [K926048](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K926048.md) | CLARUS ENDOSCOPIC BALL PROBE | Clarus Medical Systems, Inc. | Apr 7, 1993 | SESE |
| [K911932](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K911932.md) | J105 JAMES SURGICAL SYSTEM I/A PACK | O.R. Specialties, Inc. | Aug 26, 1991 | SESE |
| [K890216](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K890216.md) | MICROSURGICAL KERATOME | Kinetic Medical Products | Feb 16, 1989 | SESE |
| [K873934](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K873934.md) | RANGE OF CROCODILE ACTION INSTRUMENTS | Downs Surgical , Ltd. | Dec 17, 1987 | SESE |
| [K873933](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K873933.md) | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM | Downs Surgical , Ltd. | Dec 17, 1987 | SESE |
| [K862971](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K862971.md) | MICRA MICROSURGICAL INSTRUMENTS | Cordis Corp. | Aug 25, 1986 | SESE |
| [K853179](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K853179.md) | VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND | Keeler Instruments, Inc. | Nov 7, 1985 | SESE |
| [K853161](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K853161.md) | THE VICKERS STANDARD MICROSURGERY SET | Keeler Instruments, Inc. | Nov 7, 1985 | SESE |
| [K853181](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K853181.md) | VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED | Keeler Instruments, Inc. | Oct 28, 1985 | SESE |
| [K853180](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K853180.md) | VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED | Keeler Instruments, Inc. | Oct 28, 1985 | SESE |
| [K831071](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K831071.md) | UNIVERSAL INSTRU. SET FOR NEUROVASCULAR | Prothia USA, Inc. | Jun 8, 1983 | SESE |
| [K810485](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX/K810485.md) | DUJOVNY MICROSURGICAL SCISSORS | American V. Mueller | Feb 27, 1981 | SESE |

## Top Applicants

- Keeler Instruments, Inc. — 4 clearances
- Downs Surgical , Ltd. — 2 clearances
- American Russian Medical Services, Inc. — 1 clearance
- American V. Mueller — 1 clearance
- Clarus Medical Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZX)

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