SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR— 510(k) K052194

Name: FDA 510(k) clearance K052194
Creator: U.S. Food and Drug Administration
Published: 2005-08-24

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K052194 for SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR, Substantially Equivalent on 2005-08-24. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code ODF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-11
Decision date: 2005-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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