ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR— 510(k) K083788

Name: FDA 510(k) clearance K083788
Creator: U.S. Food and Drug Administration
Published: 2009-03-03

Substantially Equivalent

Endooptiks, Inc.

FDA 510(k) clearance K083788 for ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR, Substantially Equivalent on 2009-03-03. Applicant: Endooptiks, Inc.. Device class: 2.

Clearance details

Applicant: Endooptiks, Inc.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-19
Decision date: 2009-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Silver, NJ, US

Download summary PDF View on FDA.gov ↗

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