Home › Device types › FDS
Gastroscope And Accessories, Flexible/Rigid
FDA product code FDS · Class 2 · Gastroenterology, Urology
622
Registered devices
73,274
Adverse events
12
Recalls
76
510(k) clearances
Devices with this code
PENTAX — HOYA CORPORATIONEVIS EXERA lll COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.n.a. — Karl Storz GmbH & Co. KGUniversal Light Guide Adapter — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EXERA III XENON LIGHT SOURCE — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX — HOYA CORPORATIONLIGHTGUIDE CAP — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX — HOYA CORPORATIONDisposable Distal Cap — Micro-Tech (Nanjing) Co., Ltd.n.a. — Karl Storz GmbH & Co. KGVIDEO GASTROSCOPE — PENTAX OF AMERICA, INC.Halogen Lamp — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EXERA II COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX — HOYA CORPORATIONFUJIFILM — FUJIFILM CORPORATIONFUJIFILM — FUJIFILM CORPORATIONDISPOSABLE DISTAL ATTACHMENT — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EXERA II COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.MEDISONO — Medisono, LLCPENTAX — HOYA CORPORATIONMEDISONO — Medisono, LLCDISTAL HOOD — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EXERA lll COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Fuse — ENDOCHOICE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-31 | Olympus Corporation of the Americas | High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible repr |
| 2024-09-18 | Olympus Corporation of the Americas | To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and conc |
| 2023-07-27 | Aomori Olympus Co., Ltd. | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 |
| 2023-07-27 | Aomori Olympus Co., Ltd. | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 |
| 2022-04-22 | Olympus Corporation of the Americas | Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Oly |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin |
| 2017-02-17 | Fujifilm Medical Systems U.S.A., Inc. | Fujifilm is recalling multiple endoscopes after a retrospective review. |
| 2016-08-15 | Pentax of America Inc | PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's |
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