FGB — Ureteroscope And Accessories, Flexible/Rigid Class II
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 |
|---|---|---|---|
| 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 |
| K243857 | shanghai anqing medical instrument co | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | April 11, 2025 |
| K243708 | scivita medical technology co | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A- | March 27, 2025 |
| K243155 | dongguan zsr biomedical technology company limited | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS | February 11, 2025 |
| K243117 | hunan vathin medical instrument co | Digital Video Processor | January 29, 2025 |
| K241956 | hunan endoso life technology co | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, P | January 22, 2025 |
| K241434 | hunan vathin medical instrument co | Video Ureteroscope System | October 4, 2024 |
| K240074 | shenzhen besdata technology co | Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D | October 4, 2024 |