Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
FDA 510(k) K223864 · Brainlab AG
510(k) numberK223864
Submission
- Device name
- Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
- Applicant
- Brainlab AG
Munich, DE - Received
- December 23, 2022
- Decision date
- September 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
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Questions and answers
When was Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial cleared by the FDA?
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial (K223864) received a 510(k) decision of Substantially Equivalent on September 9, 2023, 260 days after the submission was received.
What is the product code of K223864?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.