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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190776437800 | Millennium | Avalign Technologies, Inc. | 2026-10-20 |
| B382SD9025151020 | Surgical Direct | Surgical Direct, Inc. | 2026-10-15 |
| 04058749013375 | NA | Fehling Instruments GmbH & Co. KG | 2026-10-12 |
| 04058749013818 | NA | Fehling Instruments GmbH & Co. KG | 2026-10-12 |
| 00190776436445 | Millenium | Avalign Technologies, Inc. | 2026-10-08 |
| 00724995293604 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995306304 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995306298 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995306281 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995293611 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995293598 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995293581 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995275112 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995275105 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995275099 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995275082 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995275129 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00190776400613 | Millennium | Avalign Technologies, Inc. | 2026-07-21 |
| 00190776402099 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776400415 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
| 00190776400408 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
| 00190660086343 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 00190660086350 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 00190660086367 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 00190660086374 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 00190660086381 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 00190660086398 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10885403073182 | V. Mueller | STERIS CORPORATION | 2018-08-30 |
| 10381780233190 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-02 |
| 10381780385356 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-10-31 |