Sophy Pressure Adjustable Valve System Model SM8
FDA 510(k) K013488 · Sophysa SA
510(k) numberK013488
Submission
- Device name
- Sophy Pressure Adjustable Valve System Model SM8
- Applicant
- Sophysa SA
Wellesley, MA, US - Received
- October 19, 2001
- Decision date
- March 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K222422 | Polaris Valve Electronic Reading InstrumentJXG · Traditional | 02/02/2023SE |
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| 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 Pressure Adjustable Valve System Model SM8 cleared by the FDA?
Sophy Pressure Adjustable Valve System Model SM8 (K013488) received a 510(k) decision of Substantially Equivalent on March 27, 2002, 159 days after the submission was received.
What is the product code of K013488?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.