510(k) K203226

TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM by Richard Wolf Medical Instruments Corporation — Product Code GCM

K203226 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corporation for the device "TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM". The FDA issued a decision of Substantially Equivalent on May 14, 2021. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Richard Wolf Medical Instruments Corporation has at least 10 other 510(k) clearances on record.