Codman Certas Plus Programmable Valve
FDA 510(k) K152152 · Medos International SARL
510(k) numberK152152
Submission
- Device name
- Codman Certas Plus Programmable Valve
- Applicant
- Medos International SARL
Le Locle, CH - Received
- August 3, 2015
- Decision date
- October 27, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Codman Certas Plus Programmable Valve cleared by the FDA?
Codman Certas Plus Programmable Valve (K152152) received a 510(k) decision of Substantially Equivalent on October 27, 2015, 85 days after the submission was received.
What is the product code of K152152?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.