Gemini Standard And Mini Valves

by Neurocare Group

510(k) K974708

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K974708↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK974708	Date10 Mar 1998Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K974708
FDA Product Code: JXG

Device Class: Class II
Regulation: 21 CFR Part 882.5550
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Gemini Standard and Mini Valves are central nervous system shunts and components. These devices are designed to facilitate the drainage of cerebrospinal fluid.

This device is authorized under FDA 510(k) clearance K974708. It is classified as a Class II medical device under regulation number 882.5550.