FGB — Ureteroscope And Accessories, Flexible/Rigid Class II
FDA product code FGB covers "Ureteroscope 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
- FGB
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To perform various diagnostic and therapeutic 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 |
|---|---|---|---|
| K261447 | calyxo | CVAC® Aspiration System | September 15, 2026 |
| K262488 | guangzhou red pine medical instrument co | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, | September 9, 2026 |
| K261153 | boston scientific corporation | LithoVue Elite Digital Flexible Ureteroscope System | August 26, 2026 |
| K262552 | scivita medical technology co | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | August 14, 2026 |
| K253505 | roen surgical | Zamenix P | August 7, 2026 |
| K260516 | macrolux medical technology co | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-C | July 20, 2026 |
| K252929 | anhui happiness workshop instruments co | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (M | April 9, 2026 |
| K260013 | calyxo | CVAC Image Processor | March 6, 2026 |
| K251951 | guangzhou red pine medical instrument co | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, | December 16, 2025 |
| K252468 | zhejiang geyi medical instrument co | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible | December 16, 2025 |
| K253411 | karl storz se and co. kg | Miniature Telescope for Urology (27033AA) | November 18, 2025 |
| K250917 | shenzhen sanping image technology co | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: S | October 31, 2025 |
| K252806 | shanghai anqing medical instrument co | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G- | October 3, 2025 |
| K252703 | boston scientific corporation | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure | September 24, 2025 |
| K250049 | seplou (zhuhai) co | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscop | August 26, 2025 |
| K243550 | karl storz se and co. kg | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | June 6, 2025 |
| K242699 | opcom medical | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Uretero | May 28, 2025 |
| K250785 | hunan vathin medical instrument co | Single-use Flexible Ureteroscope | May 6, 2025 |
| K243894 | sg endoscopy pte | F88 URE-SD/RD Flexible Ureteroscope | May 2, 2025 |
| K243532 | contra healthcare solutions | LumiRex Ureteroscope | April 28, 2025 |