Device type

Gastroscope And Accessories, Flexible/Rigid

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

To examine or perform procedures in the stomach. 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