Home › Device types › FED
Endoscopic Access Overtube, Gastroenterology-Urology
FDA product code FED · Class 2 · Gastroenterology, Urology
695
Registered devices
1,312
Adverse events
12
Recalls
102
510(k) clearances
Devices with this code
AquaGuide® Ureteral Access Sheath — C. R. Bard, Inc.BALLOON SHEATH — OLYMPUS MEDICAL SYSTEMS CORP.Endocuff Vision — BODDINGTONS PLASTICS LIMITEDUreteral Access Sheath — Well Lead Medical Co.,LtdGuardus — US EndoscopyForté® AXP Access Sheath — APPLIED MEDICAL RESOURCES CORPORATIONSingle-use Ureteral Access Sheath — Shenzhen HugeMed Medical Technical Development Co., Ltd.Flexor Parallel — COOK INCORPORATEDUreteral Access Sheath — Well Lead Medical Co.,LtdForté® AxP Access Sheath — APPLIED MEDICAL RESOURCES CORPORATIONCoralWell — MacroLux Medical Technology Co., Ltd.NA — Richard Wolf GmbHClearPetra — Well Lead Medical Co.,LtdN/A — Conmed CorporationNavigator HD — BOSTON SCIENTIFIC CORPORATIONClearPetra — Well Lead Medical Co.,LtdSingle Use Ureteral Access Sheath — Zhejiang Chuangxiang Medical Technology Co., LTD.CoralWell — MacroLux Medical Technology Co., Ltd.ClearPetra — Well Lead Medical Co.,LtdForté® HD Access Sheath — APPLIED MEDICAL RESOURCES CORPORATIONCoralWell — MacroLux Medical Technology Co., Ltd.Forté® HD Access Sheath — APPLIED MEDICAL RESOURCES CORPORATIONSEPLOU — SEPLOU (ZHUHAI) CO.,LTD.Guardus — US Endoscopy
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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