SOLOPASS 2.0 System
FDA 510(k) K251317 · Intravent Medical Partners
510(k) numberK251317
Submission
- Device name
- SOLOPASS 2.0 System
- Applicant
- Intravent Medical Partners
Blue Bell, PA, US - Received
- April 29, 2025
- Decision date
- September 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…HAW · Traditional | Brainlab AG | 01/28/2025SE |
More from Brainlab AG
| 510(k) | Device | Decision |
|---|---|---|
| K203251 | SOLOPASS SystemHAW · Traditional | 08/27/2021SE |
Questions and answers
When was SOLOPASS 2.0 System cleared by the FDA?
SOLOPASS 2.0 System (K251317) received a 510(k) decision of Substantially Equivalent on September 5, 2025, 129 days after the submission was received.
What is the product code of K251317?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.