FGB
- 产品代码
- FGB
- 器械名称
- Ureteroscope And Accessories, Flexible/Rigid
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.1500
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 117 件
FDA 分类定义
To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
该代码近三年的 510(k)（41 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261153 | 2026-08-26 | Boston Scientific Corporation | LithoVue Elite Digital Flexible Ureteroscope System 摘要 |
| K262552 | 2026-08-14 | Scivita Medical Technology Co., Ltd. | Single-use Flexible Ureteroscope (Single-use Flexibl 摘要 |
| K253505 | 2026-08-07 | Roen Surgical, Inc. | Zamenix P 摘要 |
| K260516 | 2026-07-20 | MacroLux Medical Technology Co., Ltd. | BubbleView Single-Use Digital Flexible Cystoscope (C 摘要 |
| K252929 | 2026-04-09 | Anhui Happiness Workshop Instruments C | Single Use Digital Flexible Ureteroscope (7.5F); Vid 摘要 |
| K260013 | 2026-03-06 | Calyxo, Inc. | CVAC Image Processor 摘要 |
| K251951 | 2025-12-16 | Guangzhou Red Pine Medical Instrument | Single-Use Video Flexible Ureterorenoscope (RP-U-C03 摘要 |
| K252468 | 2025-12-16 | Zhejiang Geyi Medical Instrument Co., | Single-use Digital Flexible Ureteroscope (GY-UR9.3); 摘要 |
| K253411 | 2025-11-18 | Karl Storz SE & CO. KG | Miniature Telescope for Urology (27033AA) 摘要 |
| K250917 | 2025-10-31 | Shenzhen Sanping Image Technology Co., | Flexible Ureterorenoscope system (Electronic Endosco 摘要 |
| K252806 | 2025-10-03 | Shanghai AnQing Medical Instrument Co. | Flexible Suction Ureterorenoscope (US27G-12-EU, US27 摘要 |
| K252703 | 2025-09-24 | Boston Scientific Corporation | LithoVue Elite Single-Use Digital Flexible Ureterosc 摘要 |
| K250049 | 2025-08-26 | Seplou (Zhuhai) Co., Ltd. | Medical Video Endoscope [Standard Deflection] (URS3 摘要 |
| K243550 | 2025-06-06 | Karl Storz SE & CO. KG | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC 摘要 |
| K242699 | 2025-05-28 | Opcom Medical, Inc. | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F2 摘要 |
| K250785 | 2025-05-06 | Hunan Vathin Medical Instrument Co., L | Single-use Flexible Ureteroscope 摘要 |
| K243894 | 2025-05-02 | Sg Endoscopy Pte, Ltd. | F88 URE-SD/RD Flexible Ureteroscope 摘要 |
| K243532 | 2025-04-28 | Contra Healthcare Solutions, LLC | LumiRex Ureteroscope 摘要 |
| K243857 | 2025-04-11 | Shanghai AnQing Medical Instrument Co. | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) 摘要 |
| K243708 | 2025-03-27 | Scivita Medical Technology Co., Ltd. | Urology Videoscope System (Single-use Flexible Uret 摘要 |
| K243155 | 2025-02-11 | Dongguan Zsr Biomedical Technology Com | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR 摘要 |
| K243117 | 2025-01-29 | Hunan Vathin Medical Instrument Co., L | Digital Video Processor 摘要 |
| K241956 | 2025-01-22 | Hunan Endoso Life Technology Co., Ltd. | Single-Use Digital Flexible Ureteroscope (PUR12-1, P 摘要 |
| K241434 | 2024-10-04 | Hunan Vathin Medical Instrument Co., L | Video Ureteroscope System |
| K240074 | 2024-10-04 | Shenzhen Besdata Technology Co., Ltd. | Single use flexible ureteroscope (UR-D1); Single use 摘要 |
| K240203 | 2024-09-05 | Dyne Medical Group, Inc. | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100 摘要 |
| K242108 | 2024-08-16 | Ambu A/S | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® 摘要 |
| K233700 | 2024-08-16 | Elmed Elektronik VE Medikal Sanayi VE | Avicenna Roboflex |
| K241945 | 2024-08-01 | Karl Storz SE & CO. KG | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); 摘要 |
| K233372 | 2024-07-25 | Karl Storz SE & CO. KG | KARL STORZ Fiber Telescopes for Urology 摘要 |
| K233778 | 2024-07-16 | Zhuhai Pusen Medical Technology Co., L | Single Use Suction Access Ureteroscope (PU400A, PU41 摘要 |
| K241639 | 2024-07-01 | Huger Medical Instrument Co., Ltd. | Single-use Video Ureterorenoscope (SVU-220US) 摘要 |
| K241598 | 2024-07-01 | Boston Scientific Corporation | LithoVue Elite Single-Use Digital Flexible Ureterosc 摘要 |
| K233630 | 2024-06-24 | Ambu A/S | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® 摘要 |
| K232911 | 2024-06-10 | Karl Storz Endovision, Inc. | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S 摘要 |
| K240374 | 2024-05-10 | Shenzhen HugeMed Medical Technical Dev | Ureterorenoscope System 摘要 |
| K233275 | 2024-03-25 | Gyrus Acmi, Inc. | RenaFlex Single-use Flexible Ureteroscope (SUURF-V S 摘要 |
| K231135 | 2024-01-17 | Hunan Vathin Medical Instrument Co., L | Video Ureteroscope System 摘要 |
| K231774 | 2024-01-11 | MacroLux Medical Technology Co., Ltd. | CoralView® Single-use Digital Flexible Ureteroscope 摘要 |
| K233645 | 2023-12-12 | Boston Scientific Corporation - | StoneSmart Connect Console, LithoVue Elite Standard 摘要 |
| K230475 | 2023-11-03 | Huger Medical Instrument Co., Ltd. | Medical Video Endoscope System 摘要 |
FDA 官方分类页： FGB
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。