Home › Device types › FGB
Ureteroscope And Accessories, Flexible/Rigid
FDA product code FGB · Class 2 · Gastroenterology, Urology
481
Registered devices
6,637
Adverse events
27
Recalls
116
510(k) clearances
Devices with this code
REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd.REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd.4K Cable 22M — OLYMPUS MEDICAL SYSTEMS CORP.SemiFlex Scope — MAXIFLEX, LLCWiScope® — Otu Medical Inc.Axis II — DORNIER MEDTECH AMERICA, INC.E-LINE — Richard Wolf GmbHIEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.WiScope® — Otu Medical Inc.Olympus — OLYMPUS Winter & Ibe GmbHAscend™ Single-Use Flexible Ureteroscope — Guangzhou Red Pine Medical Instrument Co., Ltd.Single-use Flexible Ureteroscope — Hunan Vathin Medical Instrument Co., LtdREDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd.SemiFlex Scope — MAXIFLEX, LLCF88 — SG ENDOSCOPY PTE. LTD.VISERA ELITE XENON LIGHT SOURCE — OLYMPUS MEDICAL SYSTEMS CORP.Flex-X — Karl Storz GmbH & Co. KGAptra — Otu Medical Inc.WiScope® — Otu Medical Inc.NA — STRYKER CORPORATIONSEPLOU — SEPLOU (ZHUHAI) CO.,LTD.E-LINE — Richard Wolf GmbHSingle Use Video Ureteroscope Direct In-Scope Suction — Zhuhai Pusen Medical Technology Co, LtdSlimLine — Gyrus ACMI, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 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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