Home › Device types › FGB
Ureteroscope And Accessories, Flexible/Rigid
FDA product code FGB · Class 2 · Gastroenterology, Urology
504
Registered devices
7,318
Adverse events
28
Recalls
119
510(k) clearances
Devices with this code
StoneSmart™ Connect — BOSTON SCIENTIFIC CORPORATIONAscend™ Single-Use Flexible Ureteroscope — Guangzhou Red Pine Medical Instrument Co., Ltd.RenaNav Video Processing Unit — CENTERPOINT SYSTEMS LLCn.a. — Karl Storz GmbH & Co. KGWiScope® — Ningbo Wise Optomech Technology CorporationRIWO D-URS — Richard Wolf GmbHInnovex — Shanghai AnQing Medical Instrument Co., LtdFlexible Video-Choledo-Cysto-Ureteroscope — Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)Single Use Video Ureteroscope Direct In-Scope Suction — Zhuhai Pusen Medical Technology Co, LtdE-LINE — Richard Wolf GmbHWiScope® — Otu Medical Inc.Olympus — OLYMPUS Winter & Ibe GmbHStrauss Surgical — AMERICAN MEDICAL ENDOSCOPY, INC.LithoVue — BOSTON SCIENTIFIC CORPORATIONDornier MedTech — DORNIER MEDTECH AMERICA, INC.WiScope® — Ningbo Wise Optomech Technology CorporationURETERO-RENO VIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Single-use Flexible Ureteroscope — Hunan Vathin Medical Instrument Co., LtdSingle Use Video Ureteroscope Direct In-Scope Suction — Zhuhai Pusen Medical Technology Co, LtdUscope — Zhuhai Pusen Medical Technology Co, LtdCoralView — MacroLux Medical Technology Co., Ltd.4K CAMERA HEAD — OLYMPUS MEDICAL SYSTEMS CORP.Single-use Flexible Ureteroscope — Hunan Vathin Medical Instrument Co., LtdFOOT HOLDER — OLYMPUS MEDICAL SYSTEMS CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-22 | Boston Scientific Corporation | A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power ad |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
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