FAJ — Cystoscope And Accessories, Flexible/Rigid Class II
Classification Details
- Product Code
- FAJ
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253226 | uroviu corporation | UV5000W Handle | October 23, 2025 |
| K251140 | zenflow | Zenflow Spring Scope | September 23, 2025 |
| K252598 | shanghai anqing medical instrument co | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | September 15, 2025 |
| K250797 | uroviu corporation | UV5000 Handle | September 11, 2025 |
| K243653 | karl storz se and co. kg | KARL STORZ HOPKINS Telescopes for Urology | August 13, 2025 |
| K252176 | guangzhou red pine medical instrument co | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | August 8, 2025 |
| K251652 | american medical endoscopy | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS- | August 1, 2025 |
| K250269 | ambu | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers | June 11, 2025 |
| K242535 | hunan vathin medical instrument co | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G | December 18, 2024 |
| K243196 | uroviu corporation | Uro-G HD Cystoscope (1520) | December 13, 2024 |
| K240849 | ambu | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers | October 16, 2024 |
| K240848 | ambu | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers | October 10, 2024 |
| K240227 | lina medical aps | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | August 22, 2024 |
| K241500 | guangzhou red pine medical instrument co | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cys | July 12, 2024 |
| K240663 | guangzhou red pine medical instrument co | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | June 21, 2024 |
| K240283 | macrolux medical technology co | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-C | June 10, 2024 |
| K232837 | uroviu corporation | Uro-G HD Flexible Cystoscope | June 7, 2024 |
| K231118 | shenzhen hugemed medical technical development co | Cystoscope System | November 13, 2023 |
| K223926 | medimaging integrated solution, inc (miis) | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | October 6, 2023 |
| K231702 | otu medical | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystosc | September 29, 2023 |