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)
Top companies in FDF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2024 | Olympus 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 |
FDF | K131780 |
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number PCF-H190L. Open, Classified |
FDF | K112680 |
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number CF-HQ190L. Open, Classified |
FDF | K112680 |
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number CF-HQ190I. Open, Classified |
FDF | K112680 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 17, 2023 | Aizu 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 |
FDF | K011151 K051645 +4 |
| Nov 9, 2023 | Olympus Corporation of the Americas EVIS EXERA III Gastrointestinal Videoscope Open, Classified |
FDF | K112680 |
| Apr 22, 2022 | Olympus Corporation of the Americas Colonovideoscope
Model CF-H180AL Terminated |
FDF | K100584 |
| Jul 14, 2021 | Pentax 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 |
FDF | K131855 K181084 +1 |
| Jul 14, 2021 | Pentax 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 |
FDF | K131855 K181084 +1 |
| Oct 16, 2020 | Olympus 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 |
FDF | K051541 |
| Jan 3, 2020 | Pentax of America Inc Pentax Video Colonoscope
Model: EC38-i10L Terminated |
FDF | K131855 |
| Jan 3, 2020 | Pentax of America Inc Pentax Video Colonoscope
Model: EC34-i10L Terminated |
FDF | K131855 |
| Jan 25, 2019 | Medrobotics 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 |
FDF | K162330 |
| Jan 25, 2019 | Medrobotics 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 |
FDF | K162330 |
| Nov 19, 2016 | Pentax 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 |
FDF | K131855 |
| Jul 23, 2016 | Pentax 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 |
FDF | K951574 |
| Jul 23, 2016 | Pentax 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 |
FDF | K951574 |
| Jun 28, 2016 | Pentax 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 |
FDF | K131855 K951574 +3 |
| Jan 27, 2016 | EndoChoice, Inc. Fuse 1C Colonoscope Terminated |
FDF | K141598 |
| Apr 5, 2006 | Fujinon Inc Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes. Terminated |
FDF | K041903 K944620 |
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