ELECTRODE, FLEXIBLE SUCTION COAGULATOR— 510(k) K130489

Name: FDA 510(k) clearance K130489
Creator: U.S. Food and Drug Administration
Published: 2013-04-19

Substantially Equivalent

Optim, LLC

FDA 510(k) clearance K130489 for ELECTRODE, FLEXIBLE SUCTION COAGULATOR, Substantially Equivalent on 2013-04-19. Applicant: Optim, LLC. Device class: 2.

Clearance details

Applicant: Optim, LLC
Product code: Code FEH
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2013-02-25
Decision date: 2013-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Sturbridge, MA, US

Download summary PDF View on FDA.gov ↗

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