FDA 510(k) Applications Submitted by OTU Medical Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K181977 07/24/2018 WiScope Digital Endoscope System OTU Medical Inc.
K220399 02/11/2022 WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System OTU Medical Inc.
K210579 02/26/2021 WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System OTU Medical Inc.
K231702 06/12/2023 WiScope« Digital Cystoscope System, WiScope« Single-Use Digital Flexible Cystoscope, WiScope« Medical Tablet OTU Medical Inc.
K212202 07/14/2021 WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System OTU Medical INC.


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