Cleared Special

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear

K163492 · United States Endoscopy Group, Inc. · Gastroenterology & Urology

Jan 2017

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K163492 is an FDA 510(k) clearance for the Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear, a Colonoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDF), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on January 6, 2017, 24 days after receiving the submission on December 13, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K163492 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2016
Decision Date	January 06, 2017
Days to Decision	24 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	FDF — Colonoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).