INSUFLOW CO2IONSHIELD— 510(k) K090879

Substantially Equivalent

Lexion Medical, LLC

FDA 510(k) clearance K090879 for INSUFLOW CO2IONSHIELD, Substantially Equivalent on 2009-07-23. Applicant: Lexion Medical, LLC. Device class: 2.

Clearance details

Applicant: Lexion Medical, LLC
Product code: Code FCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-03-31
Decision date: 2009-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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.