Cleared Traditional

Arc Enterocuff

K191330 · Boddingtons Plastics, Ltd. · Gastroenterology & Urology

Jan 2020

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K191330 is an FDA 510(k) clearance for the Arc Enterocuff, a Enteroscope And Accessories (Class II — Special Controls, product code FDA), submitted by Boddingtons Plastics, Ltd. (Tonbridge, GB). The FDA issued a Cleared decision on January 31, 2020, 260 days after receiving the submission on May 16, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K191330 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2019
Decision Date	January 31, 2020
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	FDA — Enteroscope And Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Provide Visualization And Perform Various Procedures Within The Small Intestine. 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).