CodMan Certas Plus Programmable Valve
FDA 510(k) K182265 · Integra Lifesciences Corp.
510(k) numberK182265
Submission
- Device name
- CodMan Certas Plus Programmable Valve
- Applicant
- Integra Lifesciences Corp.
Mansfield, MA, US - Received
- August 21, 2018
- Decision date
- November 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | Medtronic Neurosurgery | 03/10/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | Aesculap, Inc. | 12/16/2024SE |
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| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 08/22/2022SE |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special | 07/15/2022SE |
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Questions and answers
When was CodMan Certas Plus Programmable Valve cleared by the FDA?
CodMan Certas Plus Programmable Valve (K182265) received a 510(k) decision of Substantially Equivalent on November 20, 2018, 91 days after the submission was received.
What is the product code of K182265?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.