PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2— 510(k) K122593

Name: FDA 510(k) clearance K122593
Creator: U.S. Food and Drug Administration
Published: 2012-09-13

Substantially Equivalent

Optim, LLC

FDA 510(k) clearance K122593 for PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2, Substantially Equivalent on 2012-09-13. 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: 2012-08-24
Decision date: 2012-09-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Sturbridge, MA, US

Download summary PDF View on FDA.gov ↗

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