Product code GZX
- Device name
- Instrument, Microsurgical
- Medical specialty
- Neurology
- Device class
- 1
- Regulation number
- 882.4525
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932169 | MICROSURGICAL INSTRUMENTS | American Russian Medical Services, Inc. | 1993-07-20 |
| K926048 | CLARUS ENDOSCOPIC BALL PROBE | Clarus Medical Systems, Inc. | 1993-04-07 |
| K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK | O.R. Specialties, Inc. | 1991-08-26 |
| K890216 | MICROSURGICAL KERATOME | Kinetic Medical Products | 1989-02-16 |
| K873933 | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM | Downs Surgical , Ltd. | 1987-12-17 |
| K873934 | RANGE OF CROCODILE ACTION INSTRUMENTS | Downs Surgical , Ltd. | 1987-12-17 |
| K862971 | MICRA MICROSURGICAL INSTRUMENTS | Cordis Corp. | 1986-08-25 |
| K853161 | THE VICKERS STANDARD MICROSURGERY SET | Keeler Instruments, Inc. | 1985-11-07 |
| K853179 | VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND | Keeler Instruments, Inc. | 1985-11-07 |
| K853180 | VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED | Keeler Instruments, Inc. | 1985-10-28 |
| K853181 | VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED | Keeler Instruments, Inc. | 1985-10-28 |
| K831071 | UNIVERSAL INSTRU. SET FOR NEUROVASCULAR | Prothia USA, Inc. | 1983-06-08 |
| K810485 | DUJOVNY MICROSURGICAL SCISSORS | American V. Mueller | 1981-02-27 |
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|---|---|---|---|
| 00846159039689 | SCANLAN® Instrument | SCANLAN INTERNATIONAL INC | 2026-05-27 |
| 00846159039696 | SCANLAN® Scissors | SCANLAN INTERNATIONAL INC | 2026-05-27 |
| 00846159039672 | SCANLAN® Instrument | SCANLAN INTERNATIONAL INC | 2026-05-27 |
| G223150101200 | Medetz Surgical Instruments | Medetz Surgical Instruments LLC | 2023-06-15 |
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