External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
FDA 510(k) K242974 · Sophysa
510(k) numberK242974
Submission
- Device name
- External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
- Applicant
- Sophysa
Orsay, FR - Received
- September 26, 2024
- Decision date
- June 20, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | Aesculap, Inc. | 12/16/2024SE |
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More from Borvo Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring SystemGWM · Traditional | 04/10/2026SE |
| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | 11/28/2025SE |
| K222422 | Polaris Valve Electronic Reading InstrumentJXG · Traditional | 02/02/2023SE |
| K162108 | Pressio 2 ICP Monitoring SystemGWM · Traditional | 04/17/2017SE |
| K141227 | Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with SiphonxJXG · Traditional | 04/02/2015SE |
| K091328 | Siphonx Gravitational Antisiphon DeviceJXG · Traditional | 01/22/2010SE |
| K090342 | Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400JXG · Traditional | 08/11/2009SE |
| K062584 | Pressio Icp Monitoring SystemGWM · Traditional | 07/05/2007SE |
| K042481 | Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400JXG · Traditional | 12/14/2004SE |
| K031097 | Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBJXG · Traditional | 02/26/2004SE |
Questions and answers
When was External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters cleared by the FDA?
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (K242974) received a 510(k) decision of Substantially Equivalent on June 20, 2025, 267 days after the submission was received.
What is the product code of K242974?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.