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FDA 510(k)

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet

K-Number: K231702 · 2023-09-29

ApplicantOTU Medical, Inc.
Decision Date2023-09-29
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet is a medical device manufactured by OTU Medical, Inc.. It received FDA 510(k) clearance on 2023-09-29 under approval number K231702. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet?

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by OTU Medical, Inc.. The 510(k) number is K231702.

When was WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet approved by the FDA?

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet received FDA 510(k) clearance on 2023-09-29, under approval number K231702.

What company makes WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet?

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet is manufactured by OTU Medical, Inc..

What is the FDA product code for WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet?

The FDA product code for WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet is FAJ.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026)

Other Devices by OTU Medical, Inc.

K181977WiScope Digital Endoscope System K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System

Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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