Instrument, Microsurgical
FDA product code GZX · Class I (low risk) · 21 CFR 882.4525 · Neurology
13510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932169 | Microsurgical InstrumentsGZX · Traditional | American Russian Medical Services, Inc. | 07/20/1993SE |
| K926048 | Clarus Endoscopic Ball ProbeGZX · Traditional | Clarus Medical Systems, Inc. | 04/07/1993SE |
| K911932 | J105 James Surgical System I/A PackGZX · Traditional | O.R. Specialties, Inc. | 08/26/1991SE |
| K890216 | Microsurgical KeratomeGZX · Traditional | Kinetic Medical Products | 02/16/1989SE |
| K873934 | Range of Crocodile Action InstrumentsGZX · Traditional | Downs Surgical , Ltd. | 12/17/1987SE |
| K873933 | Range of Neurosurgical Instruments in TitaniumGZX · Traditional | Downs Surgical , Ltd. | 12/17/1987SE |
| K862971 | Micra Microsurgical InstrumentsGZX · Traditional | Cordis Corp. | 08/25/1986SE |
| K853179 | Vickers Ergomatic Microsur Instru-Univ R O L HandGZX · Traditional | Keeler Instruments, Inc. | 11/07/1985SE |
| K853161 | The Vickers Standard Microsurgery SetGZX · Traditional | Keeler Instruments, Inc. | 11/07/1985SE |
| K853181 | Vickers Ergomatic Micros Instr-Fine R or L HandedGZX · Traditional | Keeler Instruments, Inc. | 10/28/1985SE |
| K853180 | Vickers Ergomatic Micros Instr-Long R or L HandedGZX · Traditional | Keeler Instruments, Inc. | 10/28/1985SE |
| K831071 | Universal Instru. Set for NeurovascularGZX · Traditional | Prothia USA, Inc. | 06/08/1983SE |
| K810485 | Dujovny Microsurgical ScissorsGZX · Traditional | American V. Mueller | 02/27/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0576-2007 | AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle…A labeling discrepancy was internally identified for the surface electrode component of REF 8263210… | Medtronic Xomed, Inc. | 01/22/2007Terminated |