Uretero1 Ureteroscope System
K-Number: K211347 · 2021-11-23
ApplicantSTERIS Corporation
Decision Date2021-11-23
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Uretero1 Ureteroscope System is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2021-11-23 under approval number K211347. 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 Uretero1 Ureteroscope System?
Uretero1 Ureteroscope System is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by STERIS Corporation. The 510(k) number is K211347.
When was Uretero1 Ureteroscope System approved by the FDA?
Uretero1 Ureteroscope System received FDA 510(k) clearance on 2021-11-23, under approval number K211347.
What company makes Uretero1 Ureteroscope System?
Uretero1 Ureteroscope System is manufactured by STERIS Corporation.
What is the FDA product code for Uretero1 Ureteroscope System?
The FDA product code for Uretero1 Ureteroscope System is FGB.
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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.