StrataMR II Valves and Shunts
FDA 510(k) K212641 · Medtronic Neurosurgery
510(k) numberK212641
Submission
- Device name
- StrataMR II Valves and Shunts
- Applicant
- Medtronic Neurosurgery
Irvine, CA, US - Received
- August 20, 2021
- Decision date
- September 16, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K243205 | EvacJXG · Traditional | Phasor Health, LLC | 06/03/2025SE |
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More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | 03/10/2025SE |
| K242034 | Duet External Drainage and Monitoring System (EDMS)PCB · Special | 10/24/2024SE |
| K181622 | StrataMR guider toolJXG · Traditional | 10/01/2018SE |
| K161370 | Durepair Dura Regeneration MatrixGXQ · Traditional | 11/02/2016SE |
| K152700 | StrataMR Valves and ShuntsJXG · Traditional | 04/07/2016SE |
| K123524 | Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | 02/13/2013SE |
| K110560 | Medtronic Ares Antibiotic-Impregnated CatheterJXG · Traditional | 11/18/2011SE |
| K091312 | PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | 09/02/2009SE |
| K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836JXG · Special | 11/20/2008SE |
| K082127 | Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635JXG · Special | 08/27/2008SE |
Questions and answers
When was StrataMR II Valves and Shunts cleared by the FDA?
StrataMR II Valves and Shunts (K212641) received a 510(k) decision of Substantially Equivalent on September 16, 2021, 27 days after the submission was received.
What is the product code of K212641?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.