LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES— 510(k) K061646

Name: FDA 510(k) clearance K061646
Creator: U.S. Food and Drug Administration
Published: 2006-06-27

Substantially Equivalent

Laserscope

FDA 510(k) clearance K061646 for LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES, Substantially Equivalent on 2006-06-27. Applicant: Laserscope. Device class: 2.

Clearance details

Applicant: Laserscope
Product code: Code FBO
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-06-12
Decision date: 2006-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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