510(k) K862220
- Device
- COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
- Applicant
- STEREOTACTIC MEDICAL SYSTEMS, INC.
- 510(k) number
- K862220
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-06-18
- Date received
- 1986-06-11
- Regulation
- 882.4560
- Classification name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRUCE A KALL
- Address
- 11 Seneca Turpike New Harford NY US 13413 13413
FDA Registration Numbers#
- 8043933
- 3030412764
- 3021008900
- 3009829742
- 3021632375
- 3010123172
- 3014967969
- 9617544
- 3013176080
- 3015876273
- 3048141555
- 9610905
- 3004893332
- 3002250546
- 3002808022
- 3033536255
- 1058084
- 8039051
- 3010009632
- 3014170143
- 3013485140
- 9612277
- 1526534
- 1643264
- 3004464325
- 3043543260
- 3010363476
- 3008868758
- 3002725845
- 9613350
- 3028006458
- 1226544
- 3005874553
- 8010177
- 3002807090
- 3009293341
- 3005718816
- 3009050824
- 3010120104
- 3010120148
- 2134947
- 2245304
- 3016050940
- 3022310762
- 1835572
- 3003477135
- 3009973505
- 1057425
- 3011724582
- 3015453963
- 3015112247
- 1721676
- 2528981
- 3015542154
- 3005061536
- 1221763
- 2183456
- 3016678045
- 3012447612
- 3016245399
- 1824206
- 3003120897
- 1123169
- 3011050570
- 1836357
- 8010379
- 8043792
- 1226188
- 3020981894
- 1020279
- 3012075008
- 3023194190
- 1722447
- 3004024955
- 3017004815
- 3009108888
- 1828288
- 3000270450
- 2183744
- 3010863450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2026-09-10 |
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026-08-05 |
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026-03-26 |
| K231897 | NeuroAlign software | Medivis, Inc. | 2025-10-21 |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025-09-05 |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025-09-04 |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | 2025-07-09 |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | 2025-02-05 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG | 2025-01-28 |
| 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 |
Legacy Summary#
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FDA Review#
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