Polaris Valve Electronic Reading Instrument— 510(k) K222422

Name: FDA 510(k) clearance K222422
Creator: U.S. Food and Drug Administration
Published: 2023-02-02

Substantially Equivalent

Sophysa

FDA 510(k) clearance K222422 for Polaris Valve Electronic Reading Instrument, Substantially Equivalent on 2023-02-02. Applicant: Sophysa. Device class: 2.

Clearance details

Applicant: Sophysa
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 2022-08-11
Decision date: 2023-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orsay, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.