510(k) K220072
- Device
- Sinobot X1
- Applicant
- Sinovation (Beijing) Medical Technology Co., Ltd.
- 510(k) number
- K220072
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-18
- Date received
- 2022-01-10
- 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
- Manman Xu
- Address
- Rm.401, Bld 12-1, #26 Yongwang W. Rd., Z-Park Daxing Beijing CN 102600 102600
FDA Registration Numbers#
- 3006405073
- 3017004815
- 1834331
- 2031917
- 3010462278
- 3010863450
- 3015131155
- 3027616024
- 3004727093
- 3004188066
- 1526534
- 3004513872
- 3016438694
- 1720929
- 2245304
- 1319639
- 3009185973
- 3018094310
- 3008534770
- 3012447612
- 2528981
- 8010379
- 3006846753
- 3006697241
- 3005677016
- 1828464
- 3003120897
- 3003998208
- 3002250546
- 3011874573
- 3003935342
- 9611894
- 3008627763
- 3015797559
- 3003477135
- 3005161223
- 3004016520
- 3014251656
- 3004893332
- 9613350
- 1057425
- 8031020
- 8010177
- 3015877656
- 2183319
- 3009144915
- 2183570
- 3005216725
- 3021591288
- 1037007
- 3008110533
- 3012911444
- 2434444
- 1833920
- 3013176080
- 3004105270
- 3016577622
- 3011683674
- 3010041430
- 3010009632
- 3010209365
- 1045254
- 3005874553
- 3007366790
- 1123169
- 3016050940
- 1526439
- 1017294
- 3006639944
- 3002743211
- 1225492
- 1721676
- 3028006458
- 3009417901
- 1649518
- 3006942548
- 1424263
- 3015112247
- 1625507
Source Documents#
Other 510(k) Records For Product Code HAW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024-04-26 |