FAJ
- 产品代码
- FAJ
- 器械名称
- Cystoscope 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)
- 92 件
FDA 分类定义
To examine and perform 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)（25 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260649 | 2026-05-21 | Olympus Winter & Ibe GmbH | OES ELITE Cystoscope and Accessories; Obturator, 17 摘要 |
| K253696 | 2026-05-11 | Verathon Medical (Canada) Ulc | CFlex Cystoscope - Standard Deflection (0570-0455); 摘要 |
| K253892 | 2026-04-16 | Strauss Surgical USA | Strauss Surgical Cystoscopes & Hysteroscopes (STS-20 摘要 |
| K253905 | 2026-04-07 | Cogentix Medical, Inc. | PrimeSight UltraView System 摘要 |
| K260271 | 2026-03-27 | American Medical Endoscopy, Inc. | Strauss Surgical cystoscope, hysteroscope and access 摘要 |
| K253226 | 2025-10-23 | Uroviu Corporation | UV5000W Handle 摘要 |
| K251140 | 2025-09-23 | Zenflow, Inc. | Zenflow Spring Scope 摘要 |
| K252598 | 2025-09-15 | Shanghai AnQing Medical Instrument Co. | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-2 摘要 |
| K250797 | 2025-09-11 | Uroviu Corporation | UV5000 Handle 摘要 |
| K243653 | 2025-08-13 | Karl Storz SE & CO. KG | KARL STORZ HOPKINS Telescopes for Urology 摘要 |
| K252176 | 2025-08-08 | Guangzhou Red Pine Medical Instrument | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C0 摘要 |
| K251652 | 2025-08-01 | American Medical Endoscopy, Inc. | Strauss Surgical Cystoscopes & Hysteroscopes (STS-20 摘要 |
| K250269 | 2025-06-11 | Ambu A/S | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu 摘要 |
| K242535 | 2024-12-18 | Hunan Vathin Medical Instrument Co., L | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, 摘要 |
| K243196 | 2024-12-13 | Uroviu Corporation | Uro-G HD Cystoscope (1520) 摘要 |
| K240849 | 2024-10-16 | Ambu A/S | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu 摘要 |
| K240848 | 2024-10-10 | Ambu A/S | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu 摘要 |
| K240227 | 2024-08-22 | Lina Medical Aps | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeV 摘要 |
| K241500 | 2024-07-12 | Guangzhou Red Pine Medical Instrument | Endoscopic Video Image Processor (RP-IPD-V2000EF); S 摘要 |
| K240663 | 2024-06-21 | Guangzhou Red Pine Medical Instrument | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP- 摘要 |
| K240283 | 2024-06-10 | MacroLux Medical Technology Co., Ltd. | BubbleView Single-Use Digital Flexible Cystoscope ( 摘要 |
| K232837 | 2024-06-07 | Uroviu Corporation | Uro-G HD Flexible Cystoscope 摘要 |
| K231118 | 2023-11-13 | Shenzhen HugeMed Medical Technical Dev | Cystoscope System 摘要 |
| K223926 | 2023-10-06 | Medimaging Integrated Solution, Inc (M | VersaVue Single-Use Flexible Cystoscope, VersaVue Ta 摘要 |
| K231702 | 2023-09-29 | OTU Medical, Inc. | WiScope® Digital Cystoscope System, WiScope® Single- 摘要 |
FDA 官方分类页： FAJ
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。