FDA 510(k) Applications Submitted by April Malmborg

FDA 510(k) Number Submission Date Device Name Applicant
K200310 02/06/2020 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality Stryker
K230605 03/03/2023 1788 4K Camera System with Advanced Imaging Modality Stryker
K230754 03/17/2023 L12 LED Light Source with AIM Stryker
K181258 05/11/2018 ConnectedOR Hub with Device and Voice Control Stryker
K231854 06/23/2023 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM Stryker
K182160 08/09/2018 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM Stryker
K192292 08/23/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable Stryker
K023288 10/02/2002 COBRA BIPOLAR CLAMP, MODEL 15902 BOSTON SCIENTIFIC EP TECHNOLOGIES
K040104 01/20/2004 COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 BOSTON SCIENTIFIC CORP.
K040219 02/02/2004 COBRA SURGICAL PROBE BOSTON SCIENTIFIC CORP.
K032207 07/18/2003 COBRA COOLED SURGICAL PROBE, MODEL M004159670 BOSTON SCIENTIFIC CORP.


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