Device type

Ureteroscope And Accessories, Flexible/Rigid

Product code FGB · Class II · 21 CFR 876.1500 · Gastroenterology, Urology

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).

FDA classification database