Cleared Special

Arc Endocuff Vision

K151801 · Boddingtons Plastics, Ltd. · Gastroenterology & Urology

Aug 2015

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K151801 is an FDA 510(k) clearance for the Arc Endocuff Vision, 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 August 13, 2015, 42 days after receiving the submission on July 2, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K151801 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2015
Decision Date	August 13, 2015
Days to Decision	42 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.