Cleared Traditional

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

K230752 · Fujifilm Healthcare Americas Corporation · Gastroenterology & Urology

Sep 2023

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K230752 is an FDA 510(k) clearance for the Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A), a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on September 15, 2023, 182 days after receiving the submission on March 17, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K230752 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2023
Decision Date	September 15, 2023
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

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.