About This 510(k) Submission
K203226 is an FDA 510(k) clearance for the 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, a Endoscope, Rigid (Class II — Special Controls, product code GCM), submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on May 14, 2021, 193 days after receiving the submission on November 2, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.