Home › Device types › FDF
Colonoscope And Accessories, Flexible/Rigid
FDA product code FDF · Class 2 · Gastroenterology, Urology
0
Registered devices
84,519
Adverse events
25
Recalls
115
510(k) clearances
Devices with this code
SUCTION VALVE — OLYMPUS MEDICAL SYSTEMS CORP.COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX — HOYA CORPORATIONDEFENDO — MEDIVATORS INC.DEFENDO Air/Water/Suction and Biopsy Valve — MEDIVATORS INC.G-EYE Colonoscope — SMART MEDICAL SYSTEMS LTDFuse® — ENDOCHOICE, INC.n.a. — Karl Storz GmbH & Co. KGPENTAX — HOYA CORPORATIONG-EYE Colonoscope — SMART MEDICAL SYSTEMS LTDEVIS EXERA lll COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Endoch — Endoch IncPENTAX — HOYA CORPORATIONFUJIFILM — FUJIFILM CORPORATIONHAND COIL COVER — OLYMPUS MEDICAL SYSTEMS CORP.G-EYE Colonoscope — SMART MEDICAL SYSTEMS LTDFUJIFILM — FUJIFILM CORPORATIONVIDEO COLONOSCOPE — PENTAX OF AMERICA, INC.SPARE FUSE — OLYMPUS MEDICAL SYSTEMS CORP.FUJIFILM — FUJIFILM CORPORATIONEndoch — Endoch IncEVIS EXERA II COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Pure-Vu EVS COLON KIT, 5 Pack — MOTUS GI MEDICAL TECHNOLOGIES LTDFUJIFILM — FUJIFILM CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-02 | Olympus Corporation of the Americas | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the |
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