proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
FDA 510(k) K161853 · Aesculap, Inc.
510(k) numberK161853
Submission
- Device name
- proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- July 6, 2016
- Decision date
- February 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System cleared by the FDA?
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System (K161853) received a 510(k) decision of Substantially Equivalent on February 27, 2017, 236 days after the submission was received.
What is the product code of K161853?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.