Device type

System, Surgical, Computer Controlled Instrument

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

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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