Gemini Standard and Mini Valves

FDA 510(k) K974708 · Neurocare Group

Substantially Equivalent

510(k) numberK974708

Submission

Device name
Gemini Standard and Mini Valves
Applicant
Neurocare Group
Pleasant Prairie, WI, US
Received
December 17, 1997
Decision date
March 10, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

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K243205EvacJXG · Traditional Phasor Health, LLC06/03/2025SE
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Questions and answers

When was Gemini Standard and Mini Valves cleared by the FDA?

Gemini Standard and Mini Valves (K974708) received a 510(k) decision of Substantially Equivalent on March 10, 1998, 83 days after the submission was received.

What is the product code of K974708?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.