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

Endoscopic Ultrasound System, Gastroenterology-Urology

Regulation 876.1500

2510(k)s in 12 months (44 all time)
4recalls in 12 months (14 all time)
14recalls that name a 510(k)
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Top companies in ODG

Company510(k)sRecalls
Pentax of America, Inc.66
Boston Scientific80
Pentax Precision Instrument Corp.70
Olympus Corporation of the Americas05
Fujifilm Corporation40
Micro-Tech (Nanjing) Co., Ltd.22
Pentax Medical Company31
Olympus Optical Co., Ltd.30
Olympus Corp.20
Olympus America, Inc.20
DateFirm and productCodeLinked 510(k)
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
Open, Classified		 ODGK182004
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
Open, Classified		 ODGK182004
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
Open, Classified		 ODGK200090
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
Open, Classified		 ODGK200090
Oct 16, 2020Olympus Corporation of the Americas
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Terminated		 ODGK010591
Oct 16, 2020Olympus Corporation of the Americas
Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Terminated		 ODGK010591
Oct 16, 2020Olympus Corporation of the Americas
Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Terminated		 ODGK011886
Oct 16, 2020Olympus Corporation of the Americas
Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal
Terminated		 ODGK926514
Mar 12, 2018Micro-Tech (Nanjing) Co., Ltd.
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Terminated		 ODGK172309
Mar 12, 2018Micro-Tech (Nanjing) Co., Ltd.
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Terminated		 ODGK172309
May 23, 2017Pentax of America Inc
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video
Terminated		 ODGK090197
K130247
May 23, 2017Pentax of America Inc
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical vide
Terminated		 ODGK061068
K090196 +1
Jul 23, 2016Pentax Medical Company
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricte
Terminated		 ODGK961974
Sep 28, 2015Olympus Corporation of the Americas
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastr
Terminated		 ODGK093395

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