510(k) K931991
- Device
- GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
- Applicant
- NOMOS CORP.
- 510(k) number
- K931991
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-20
- Date received
- 1993-04-22
- 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
- No
Applicant Contact#
- Contact
- MARVIN L SUSSMAN
- Address
- 7800 Red Rd. Suite 330-D South Miami FL US 33143 33143
FDA Registration Numbers#
- 3018708317
- 1720929
- 3008837339
- 3007515069
- 9610905
- 3002250546
- 9710332
- 3025603301
- 3002725845
- 3010123206
- 3014479313
- 2182979
- 1928237
- 2183456
- 2245304
- 1037007
- 8043933
- 8040537
- 3008114965
- 3011050570
- 3021008900
- 1047843
- 3017210488
- 3010032903
- 2424366
- 3005075696
- 1226188
- 2030624
- 3017004815
- 3009293341
- 3004608878
- 3009829742
- 3014342096
- 3006942548
- 3010370554
- 3003120897
- 1222313
- 2434444
- 1048735
- 3010822102
- 3010362364
- 3027375826
- 1058084
- 3011724582
- 3008027912
- 3003935342
- 3014967969
- 3004024955
- 3013726944
- 3011683674
- 3004893332
- 3010120148
- 8010379
- 3012469182
- 3023194190
- 3010049501
- 3006405073
- 3004753785
- 3009185973
- 3018094310
- 1057425
- 9610612
- 1834331
- 1020279
- 3010363476
- 1625507
- 3010197224
- 1225492
- 3015797559
- 9612277
- 1824206
- 2244478
- 3006639944
- 3028006458
- 3016678045
- 3008627763
- 3010120135
- 3011874573
- 3006697241
Source Documents#
Other 510(k) Records For Product Code HAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 |
| K233141 | SmartFrame OR | ClearPoint Neuro, Inc. | 2024-01-12 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases