Instrument, Microsurgical
The Microsurgical Instrument is a precision hand-held tool used in neurosurgical procedures performed under magnification, including delicate dissection, manipulation, and tissue handling in procedures on the brain, spinal cord, and peripheral nerves. It is classified as a Class 1 device (lowest risk), subject to general controls only, reflecting its basic mechanical nature. The product code is GZX under regulation 21 CFR 882.4525 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- GZX
- Device Class
- FDA class 1
- Regulation Number
- 882.4525
- 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 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932169 | MICROSURGICAL INSTRUMENTS | Jul 20, 1993 | Substantially Equivalent | American Russian Medical Services, Inc. |
| K926048 | CLARUS ENDOSCOPIC BALL PROBE | Apr 07, 1993 | Substantially Equivalent | Clarus Medical Systems, Inc. |
| K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK | Aug 26, 1991 | Substantially Equivalent | O.R. Specialties, Inc. |
| K890216 | MICROSURGICAL KERATOME | Feb 16, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K873934 | RANGE OF CROCODILE ACTION INSTRUMENTS | Dec 17, 1987 | Substantially Equivalent | Downs Surgical , Ltd. |
| K873933 | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM | Dec 17, 1987 | Substantially Equivalent | Downs Surgical , Ltd. |
| K862971 | MICRA MICROSURGICAL INSTRUMENTS | Aug 25, 1986 | Substantially Equivalent | Cordis Corp. |
| K853179 | VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND | Nov 07, 1985 | Substantially Equivalent | Keeler Instruments, Inc. |
| K853161 | THE VICKERS STANDARD MICROSURGERY SET | Nov 07, 1985 | Substantially Equivalent | Keeler Instruments, Inc. |
| K853181 | VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED | Oct 28, 1985 | Substantially Equivalent | Keeler Instruments, Inc. |
| K853180 | VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED | Oct 28, 1985 | Substantially Equivalent | Keeler Instruments, Inc. |
| K831071 | UNIVERSAL INSTRU. SET FOR NEUROVASCULAR | Jun 08, 1983 | Substantially Equivalent | Prothia USA, Inc. |
| K810485 | DUJOVNY MICROSURGICAL SCISSORS | Feb 27, 1981 | Substantially Equivalent | American V. Mueller |
FEI Numbers
This FDA classification entry is associated with 136 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 136 registration numbers. Click on an entry to view related FDA registrations.