Home › Device types › FED
Endoscopic Access Overtube, Gastroenterology-Urology
FDA product code FED · Class 2 · Gastroenterology, Urology
716
Registered devices
1,336
Adverse events
12
Recalls
105
510(k) clearances
Devices with this code
Ureteral Access Sheath — Well Lead Medical Co.,LtdClearPetra — Well Lead Medical Co.,LtdReTrace — Coloplast A/SSidecar External Working Channel — C2 THERAPEUTICS, INC.Pathfinder® — NEPTUNE MEDICAL INC.ClearPetra — Well Lead Medical Co.,LtdNavigator — BOSTON SCIENTIFIC CORPORATIONSingle Use Video Ureteroscope Direct In-Scope Suction — Zhuhai Pusen Medical Technology Co, LtdNA — Richard Wolf GmbHNA — SCHÖLLY FIBEROPTIC GmbHClearPetra — Well Lead Medical Co.,LtdClearPetra — Well Lead Medical Co.,LtdGuardus — US EndoscopyTrious — Shenzhen Trious Medical Technology Co., LtdForté® HD Access Sheath — APPLIED MEDICAL RESOURCES CORPORATIONSingle-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., LtdAquaGuide® Ureteral Access Sheath — C. R. Bard, Inc.Endo-Ease Vista Retrograde — SPIRUS MEDICAL LLCGuardus — US EndoscopyFlexor Parallel — COOK INCORPORATEDSingle Use Video Ureteroscope Direct In-Scope Suction — Zhuhai Pusen Medical Technology Co, LtdAmplifEYE — MEDIVATORS INC.ClearPetra — Well Lead Medical Co.,LtdYiGaoMed — Zhejiang Yigao Medical Technology Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-19 | Calyxo, Inc. | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patien |
| 2024-11-27 | Trokamed GmbH | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly bu |
| 2024-11-27 | Trokamed GmbH | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly bu |
| 2024-11-27 | Trokamed GmbH | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly bu |
| 2024-11-27 | Trokamed GmbH | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly bu |
| 2021-08-03 | Olympus Corporation of the Americas | Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection. |
| 2020-03-11 | Boddingtons Plastics Ltd | Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device |
| 2013-11-05 | Boston Scientific Corporation | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the |
| 2013-11-05 | Boston Scientific Corporation | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the |
| 2013-11-05 | Boston Scientific Corporation | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the |
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