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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| 00190776407414 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| 00190776422271 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| 00190776407322 | Millennium | Avalign Technologies, Inc. | 2026-07-28 |
| 00190776404093 | Millennium | Avalign Technologies, Inc. | 2026-07-24 |
| 00190776404116 | Millennium | Avalign Technologies, Inc. | 2026-07-24 |
| 00190776404123 | Millennium | Avalign Technologies, Inc. | 2026-07-24 |
| 00190776404130 | Millennium | Avalign Technologies, Inc. | 2026-07-24 |
| 00190776404086 | Millennium | Avalign Technologies, Inc. | 2026-07-22 |
| 00190776400613 | Millennium | Avalign Technologies, Inc. | 2026-07-21 |
| 00190776403386 | Millennium | Avalign Technologies, Inc. | 2026-07-21 |
| 00650551006978 | PMT® SUCTION INSTRUMENTS | PMT CORPORATION | 2026-07-20 |
| 00190776402099 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776400415 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
| 00190776400408 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
| 00190776395681 | Millennium | Avalign Technologies, Inc. | 2026-07-14 |
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