Panendoscope (Gastroduodenoscope)

FDA product code FAK · Class II (moderate risk) · 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).

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K812810Pentax Flexible DriodenofiberscopeFAK · Traditional Pentax Precision Instrument Corp.11/17/1981SE
K760822Model TX-8 PanendoscopeFAK · Traditional American Cystocope Makers, Inc.10/21/1976SE