Home › Device types › FET
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FDA product code FET · Class 2 · Gastroenterology, Urology
362
Registered devices
61,447
Adverse events
8
Recalls
100
510(k) clearances
Devices with this code
NA — SCHÖLLY FIBEROPTIC GmbHAir/Water Spray Valve — OLYMPUS MEDICAL SYSTEMS CORP.EleVision™ — SCHÖLLY FIBEROPTIC GmbHKEYBOARD — OLYMPUS MEDICAL SYSTEMS CORP.NA — SCHÖLLY FIBEROPTIC GmbHSemi-disposable Biopsy Valve — OLYMPUS MEDICAL SYSTEMS CORP.N/A — PENTAX OF AMERICA, INC.EVIS EXERA DUODENOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Gas/Water Valve — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EXERA COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.NA — SCHÖLLY FIBEROPTIC GmbHNA — SCHÖLLY FIBEROPTIC GmbHGimmi — Gimmi GmbHNA — SCHÖLLY FIBEROPTIC GmbHDistal cover — OLYMPUS MEDICAL SYSTEMS CORP.12G-SDI cable 8.5M — OLYMPUS MEDICAL SYSTEMS CORP.Air/water valve — OLYMPUS MEDICAL SYSTEMS CORP.ENDOCAM — Richard Wolf GmbHNA — SCHÖLLY FIBEROPTIC GmbHNA — SCHÖLLY FIBEROPTIC GmbHAW channel cleaning adapte — OLYMPUS MEDICAL SYSTEMS CORP.EleVision™ — SCHÖLLY FIBEROPTIC GmbHEXALT™ — BOSTON SCIENTIFIC CORPORATIONWATER CONTAINER (O-RING) — OLYMPUS MEDICAL SYSTEMS CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-21 | Olympus Corporation of the Americas | It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifi |
| 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 |
| 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 |
| 2018-05-11 | Olympus Corporation of the Americas | Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps d |
| 2018-05-11 | Olympus Corporation of the Americas | Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating |
| 2016-06-20 | Karl Storz Endoscopy | Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope a |
| 2015-06-30 | Fujifilm Medical Systems U.S.A., Inc. | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operatio |
| 2015-06-30 | Fujifilm Medical Systems U.S.A., Inc. | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operatio |
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