Sophy SU8 Pressure Adjustable Valve
FDA 510(k) K992465 · Sophysa SA
510(k) numberK992465
Submission
- Device name
- Sophy SU8 Pressure Adjustable Valve
- Applicant
- Sophysa SA
Wellesley, MA, US - Received
- July 23, 1999
- Decision date
- September 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Aesculap, 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 |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional | 06/20/2025SE |
| 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 |
Questions and answers
When was Sophy SU8 Pressure Adjustable Valve cleared by the FDA?
Sophy SU8 Pressure Adjustable Valve (K992465) received a 510(k) decision of Substantially Equivalent on September 21, 2000, 426 days after the submission was received.
What is the product code of K992465?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.