510(k) K020764
- Device
- NAVIPRO
- Applicant
- Kinamed, Inc.
- 510(k) number
- K020764
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-03
- Date received
- 2002-03-07
- Regulation
- 882.4560
- Classification name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- VINEET K SARIN
- Address
- 820 Flynn Rd. Camarillo CA US 93012 93012
FDA Registration Numbers#
- 9612277
- 3010120104
- 2424366
- 3005545216
- 3013557562
- 3008812560
- 3015876273
- 2032112
- 3016678045
- 3036756245
- 3008738628
- 3003935342
- 3004142400
- 3009185973
- 9613350
- 3010197224
- 2133772
- 3014479313
- 3010120135
- 8039051
- 9610612
- 3004753785
- 3003418325
- 3021632375
- 3009970070
- 3015536273
- 3009829742
- 3005161223
- 3009959868
- 3022232775
- 3017210488
- 9610905
- 1720929
- 3016050940
- 3004727093
- 1721983
- 3017565094
- 3022310762
- 2134947
- 3020981894
- 3007539489
- 3010370554
- 3013726944
- 3015877656
- 3013302242
- 9611894
- 3014170143
- 3006783837
- 3012447612
- 3003477135
- 3015797559
- 3019767615
- 3021008900
- 1057425
- 3023194190
- 2031093
- 3017004815
- 3003955307
- 3004464325
- 1424263
- 3015207155
- 3010362364
- 3010047454
- 3027375826
- 3003525643
- 1723170
- 3015232217
- 3016245399
- 1625507
- 3012911444
- 3009888740
- 3011724582
- 1828464
- 3000270450
- 2183744
- 3015542154
- 1045254
- 3005180920
- 3033536255
Source Documents#
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| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025-01-24 |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025-01-17 |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024-12-27 |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-10-04 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | 2024-01-12 |