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— 510(k) K203226

Clearance details

Applicant

Richard Wolf Medical Instruments Corporation

Product code

Code GCM

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2020-11-02

Decision date

2021-05-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vernon Hills, IL, US

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Malfunction

1,233

Total

1,233

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →