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

Colonoscope And Accessories, Flexible/Rigid

Regulation 876.1500

5510(k)s in 12 months (115 all time)
0recalls in 12 months (25 all time)
25recalls that name a 510(k)
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Top companies in FDF

DateFirm and productCodeLinked 510(k)
Oct 11, 2024Olympus Corporation of the Americas
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for e
Open, Classified
FDFK131780
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number PCF-H190L.
Open, Classified
FDFK112680
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number CF-HQ190L.
Open, Classified
FDFK112680
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number CF-HQ190I.
Open, Classified
FDFK112680
Nov 29, 2023Aizu Olympus Co., Ltd.
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Open, Classified
FDFK131780
Nov 29, 2023Aizu Olympus Co., Ltd.
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Open, Classified
FDFK131780
Nov 29, 2023Aizu Olympus Co., Ltd.
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Open, Classified
FDFK131780
Nov 29, 2023Aizu Olympus Co., Ltd.
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Open, Classified
FDFK131780
Nov 29, 2023Aizu Olympus Co., Ltd.
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Open, Classified
FDFK131780
Nov 17, 2023Aizu Olympus Co., Ltd.
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170
Open, Classified
FDFK011151
K051645 +4
Nov 9, 2023Olympus Corporation of the Americas
EVIS EXERA III Gastrointestinal Videoscope
Open, Classified
FDFK112680
Apr 22, 2022Olympus Corporation of the Americas
Colonovideoscope Model CF-H180AL
Terminated
FDFK100584
Jul 14, 2021Pentax of America Inc
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i
Open, Classified
FDFK131855
K181084 +1
Jul 14, 2021Pentax of America Inc
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi,
Open, Classified
FDFK131855
K181084 +1
Oct 16, 2020Olympus Corporation of the Americas
Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
Terminated
FDFK051541
Jan 3, 2020Pentax of America Inc
Pentax Video Colonoscope Model: EC38-i10L
Terminated
FDFK131855
Jan 3, 2020Pentax of America Inc
Pentax Video Colonoscope Model: EC34-i10L
Terminated
FDFK131855
Jan 25, 2019Medrobotics Corporation
Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is in
Terminated
FDFK162330
Jan 25, 2019Medrobotics Corporation
Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is in
Terminated
FDFK162330
Nov 19, 2016Pentax of America Inc
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancilla
Terminated
FDFK131855
Jul 23, 2016Pentax Medical Company
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue
Terminated
FDFK951574
Jul 23, 2016Pentax Medical Company
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue
Terminated
FDFK951574
Jun 28, 2016Pentax Medical Company
Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems
Terminated
FDFK131855
K951574 +3
Jan 27, 2016EndoChoice, Inc.
Fuse 1C Colonoscope
Terminated
FDFK141598
Apr 5, 2006Fujinon Inc
Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.
Terminated
FDFK041903
K944620

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