CYBERWAND LITHOTRIPTER— 510(k) K102169

Substantially Equivalent

Cybersonics, Inc.

FDA 510(k) clearance K102169 for CYBERWAND LITHOTRIPTER, Substantially Equivalent on 2010-08-30. Applicant: Cybersonics, Inc.. Device class: 2.

Clearance details

Applicant: Cybersonics, Inc.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 2010-08-02
Decision date: 2010-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Erie, PA, 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.