Panels › Gastroenterology, Urology › Product code FDS · Class 2
Gastroscope And Accessories, Flexible/Rigid
Regulation 876.1500
8510(k)s in 12 months (79 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in FDS
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujifilm Corporation | 15 | 0 |
| Pentax Precision Instrument Corp. | 7 | 0 |
| Fujinon, Inc. | 5 | 1 |
| Pentax of America, Inc. | 5 | 1 |
| Olympus Medical Systems Corp. | 5 | 0 |
| Olympus Corporation of the Americas | 0 | 5 |
| EvoEndo, Inc. | 4 | 0 |
| Olympus Optical Co., Ltd. | 4 | 0 |
| Ambu A/S | 3 | 0 |
| Olympus America, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2024 | Olympus Corporation of the Americas EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 Open, Classified |
FDS | K232997 |
| Nov 20, 2024 | Olympus Corporation of the Americas Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190
Product Name: Olympus GIF-1TH190
Model/Catalog Number: GIF-1TH190
Software Version: N/A
Product Description: This instrument is intend Open, Classified |
FDS | K232997 |
| Sep 7, 2023 | Aomori Olympus Co., Ltd. Reusable distal attachments
Models:
MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290 Open, Classified |
FDS | K984358 |
| Sep 7, 2023 | Aomori Olympus Co., Ltd. Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.
Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012 Open, Classified |
FDS | K984358 |
| Apr 22, 2022 | Olympus Corporation of the Americas EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
Model: GIF-HQ190 Open, Classified |
FDS | None listed |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor Terminated |
FDS | K971660 |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Terminated |
FDS | K971660 |
| Feb 17, 2017 | Fujifilm Medical Systems U.S.A., Inc. Ultrasonic Endoscope
Model Number EG-530UT
A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs Terminated |
FDS | K063847 |
| Oct 26, 2016 | Pentax of America Inc Pentax Video Gastroscope 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 |
FDS | K131902 |
| Jun 28, 2016 | Pentax Medical Company Gastroscope
Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems Terminated |
FDS | K131902 K850020 +3 |
| Jul 24, 2014 | Pentax Medical Company EG-3630U Ultrasound Video Gastroscope
EG-3830UT Ultrasound Video Gastroscope
EG-3870UTK Ultrasound Video Gastroscope
FG-36UX Ultrasound Fiber Gastroscope
Used to provide optical and sonographic visu Terminated |
FDS | K041396 K041397 |
| Oct 30, 2013 | Fujinon Inc Fujinon/Fujifilm Ultrasonic Endoscope
Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment Terminated |
FDS | K120446 |
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