FAJ — Cystoscope And Accessories, Flexible/Rigid Class II
FDA product code FAJ covers "Cystoscope And Accessories, Flexible/Rigid", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260649 | Olympus Winter And Ibe | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 1 | May 21, 2026 |
| K253696 | Verathon Medical (Canada) Ulc | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse D | May 11, 2026 |
| K253892 | Strauss Surgical Usa | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x | Apr 16, 2026 |
| K253905 | Cogentix Medical | PrimeSight UltraView System | Apr 7, 2026 |
| K260271 | American Medical Endoscopy | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | Mar 27, 2026 |
| K253226 | Uroviu Corporation | UV5000W Handle | Oct 23, 2025 |
| K251140 | Zenflow | Zenflow Spring Scope | Sep 23, 2025 |
| K252598 | Shanghai Anqing Medical Instrument Co | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Sep 15, 2025 |
| K250797 | Uroviu Corporation | UV5000 Handle | Sep 11, 2025 |
| K243653 | Karl Storz Se And Co. Kg | KARL STORZ HOPKINS Telescopes for Urology | Aug 13, 2025 |
| K252176 | Guangzhou Red Pine Medical Instrument Co | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Aug 8, 2025 |
| K251652 | American Medical Endoscopy | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS- | Aug 1, 2025 |
| K250269 | Ambu | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers | Jun 11, 2025 |
| K242535 | Hunan Vathin Medical Instrument Co | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G | Dec 18, 2024 |
| K243196 | Uroviu Corporation | Uro-G HD Cystoscope (1520) | Dec 13, 2024 |
| K240849 | Ambu | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers | Oct 16, 2024 |
| K240848 | Ambu | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers | Oct 10, 2024 |
| K240227 | Lina Medical Aps | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | Aug 22, 2024 |
| K241500 | Guangzhou Red Pine Medical Instrument Co | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cys | Jul 12, 2024 |
| K240663 | Guangzhou Red Pine Medical Instrument Co | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | Jun 21, 2024 |