Synexis Sphere Rx— 510(k) K221540

Substantially Equivalent

Synexis, LLC

FDA 510(k) clearance K221540 for Synexis Sphere Rx, Substantially Equivalent on 2023-06-14. Applicant: Synexis, LLC. Device class: 2.

Clearance details

Applicant: Synexis, LLC
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2022-05-27
Decision date: 2023-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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