FAJ
- Product code
- FAJ
- Device name
- Cystoscope And Accessories, Flexible/Rigid
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 92
FDA classification definition
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).
510(k) clearances, last 3 years (25)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K260649 | 2026-05-21 | Olympus Winter & Ibe GmbH | OES ELITE Cystoscope and Accessories; Obturator, 17 summary |
| K253696 | 2026-05-11 | Verathon Medical (Canada) Ulc | CFlex Cystoscope - Standard Deflection (0570-0455); summary |
| K253892 | 2026-04-16 | Strauss Surgical USA | Strauss Surgical Cystoscopes & Hysteroscopes (STS-20 summary |
| K253905 | 2026-04-07 | Cogentix Medical, Inc. | PrimeSight UltraView System summary |
| K260271 | 2026-03-27 | American Medical Endoscopy, Inc. | Strauss Surgical cystoscope, hysteroscope and access summary |
| K253226 | 2025-10-23 | Uroviu Corporation | UV5000W Handle summary |
| K251140 | 2025-09-23 | Zenflow, Inc. | Zenflow Spring Scope summary |
| K252598 | 2025-09-15 | Shanghai AnQing Medical Instrument Co. | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-2 summary |
| K250797 | 2025-09-11 | Uroviu Corporation | UV5000 Handle summary |
| K243653 | 2025-08-13 | Karl Storz SE & CO. KG | KARL STORZ HOPKINS Telescopes for Urology summary |
| K252176 | 2025-08-08 | Guangzhou Red Pine Medical Instrument | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C0 summary |
| K251652 | 2025-08-01 | American Medical Endoscopy, Inc. | Strauss Surgical Cystoscopes & Hysteroscopes (STS-20 summary |
| K250269 | 2025-06-11 | Ambu A/S | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu summary |
| K242535 | 2024-12-18 | Hunan Vathin Medical Instrument Co., L | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, summary |
| K243196 | 2024-12-13 | Uroviu Corporation | Uro-G HD Cystoscope (1520) summary |
| K240849 | 2024-10-16 | Ambu A/S | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu summary |
| K240848 | 2024-10-10 | Ambu A/S | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu summary |
| K240227 | 2024-08-22 | Lina Medical Aps | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeV summary |
| K241500 | 2024-07-12 | Guangzhou Red Pine Medical Instrument | Endoscopic Video Image Processor (RP-IPD-V2000EF); S summary |
| K240663 | 2024-06-21 | Guangzhou Red Pine Medical Instrument | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP- summary |
| K240283 | 2024-06-10 | MacroLux Medical Technology Co., Ltd. | BubbleView Single-Use Digital Flexible Cystoscope ( summary |
| K232837 | 2024-06-07 | Uroviu Corporation | Uro-G HD Flexible Cystoscope summary |
| K231118 | 2023-11-13 | Shenzhen HugeMed Medical Technical Dev | Cystoscope System summary |
| K223926 | 2023-10-06 | Medimaging Integrated Solution, Inc (M | VersaVue Single-Use Flexible Cystoscope, VersaVue Ta summary |
| K231702 | 2023-09-29 | OTU Medical, Inc. | WiScope® Digital Cystoscope System, WiScope® Single- summary |
Official FDA classification page: FAJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).