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