FDA 510(k) Applications Submitted by Gyrus ACMI, Inc

FDA 510(k) Number Submission Date Device Name Applicant
K233275 09/29/2023 RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) Gyrus ACMI, Inc
K181696 06/27/2018 ChitoZolve Gyrus ACMI, Inc
K152744 09/23/2015 DIEGO ELITE DRILL GYRUS ACMI, INC


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