Cleared Special

Arc Endocuff Glide AEG110 & AEG120

K191067 · Boddingtons Plastics, Ltd. · Gastroenterology & Urology

May 2019

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K191067 is an FDA 510(k) clearance for the Arc Endocuff Glide AEG110 & AEG120, a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by Boddingtons Plastics, Ltd. (Tonbridge, GB). The FDA issued a Cleared decision on May 30, 2019, 38 days after receiving the submission on April 22, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K191067 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2019
Decision Date	May 30, 2019
Days to Decision	38 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	FED — Endoscopic Access Overtube, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.