Panels › Gastroenterology, Urology › Product code FET · Class 2

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Regulation 876.1500

3510(k)s in 12 months (101 all time)

0recalls in 12 months (8 all time)

8recalls that name a 510(k)

Get daily alerts for FET Sample brief CSV

Top companies in FET

Company	510(k)s	Recalls
KARL STORZ Endoscopy-America, Inc.	13	0
Olympus Medical Systems Corp.	10	0
Richard Wolf Medical Instruments Corp.	8	0
Karl Storz Imaging, Inc.	5	0
Fujifilm Corporation	3	0
Fujinon, Inc.	3	0
Olympus America, Inc.	3	0
Olympus Corporation of the Americas	0	3
Precise Optics	3	0
Aizu Olympus Co., Ltd.	0	2

Date	Firm and product	Code	Linked 510(k)
Oct 23, 2024	Olympus Corporation of the Americas Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 Open, Classified	FET	K222584
Nov 17, 2023	Aizu Olympus Co., Ltd. Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V. Open, Classified	FET	K143153 K193182 +1
Nov 17, 2023	Aizu Olympus Co., Ltd. Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170 Open, Classified	FET	K001241 K051645 +4
May 11, 2018	Olympus Corporation of the Americas Olympus JF-160F duodenoscopes (Model NumberJF-160F) Terminated	FET	K853585
May 11, 2018	Olympus Corporation of the Americas Olympus JF-140F duodenoscopes (Model NumberJF-140F) Terminated	FET	K853585
Jul 6, 2016	Karl Storz Endoscopy Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope Terminated	FET	K131953
Sep 22, 2015	Fujifilm Medical Systems U.S.A., Inc. Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images. Terminated	FET	K944759
Sep 22, 2015	Fujifilm Medical Systems U.S.A., Inc. Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures. Terminated	FET	K944759

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.