WiScope Digital Endoscope System
K-Number: K181977 · 2018-08-14
ApplicantOTU Medical, Inc.
Decision Date2018-08-14
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
WiScope Digital Endoscope System is a medical device manufactured by OTU Medical, Inc.. It received FDA 510(k) clearance on 2018-08-14 under approval number K181977. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the WiScope Digital Endoscope System?
WiScope Digital Endoscope System is a medical device that received FDA 510(k) clearance on 2018-08-14. It is manufactured by OTU Medical, Inc.. The 510(k) number is K181977.
When was WiScope Digital Endoscope System approved by the FDA?
WiScope Digital Endoscope System received FDA 510(k) clearance on 2018-08-14, under approval number K181977.
What company makes WiScope Digital Endoscope System?
WiScope Digital Endoscope System is manufactured by OTU Medical, Inc..
What is the FDA product code for WiScope Digital Endoscope System?
The FDA product code for WiScope Digital Endoscope System is FGB.
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Other Devices by OTU Medical, Inc.
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
K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.