FDA 510(k) Applications Submitted by KARL STORZ ENDOSCOPY AMERICA, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K221004 04/05/2022 HOPKINS Telescopes KARL STORZ Endoscopy America, Inc.
K213194 09/29/2021 HD Mediastinoscope Karl Storz Endoscopy America, Inc.
K150969 04/13/2015 Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces KARL STORZ ENDOSCOPY AMERICA, INC.
K223885 12/27/2022 HOPKINS Telescopes Karl Storz Endoscopy America, Inc.
K161555 06/06/2016 KARL STORZ NAV1 Electromagnetic Navigation System KARL STORZ Endoscopy America, Inc.
K222504 08/18/2022 H1 Karl Storz Endoscopy America, Inc.
K160044 01/08/2016 Image1 SPIES System KARL STORZ ENDOSCOPY AMERICA, INC.
K180146 01/18/2018 KARL STORZ ICG Imaging System KARL STORZ Endoscopy America, Inc.
K200965 04/10/2020 XR-MX/1000 KARL STORZ Endoscopy America, Inc.
K151044 04/20/2015 CLICKLINE Scissor Insert for Single Use KARL STORZ Endoscopy America, Inc.
K201096 04/24/2020 CO2mbiLED Karl Storz Endoscopy America, Inc.
K212476 08/06/2021 KARL STORZ Flexible HD Cysto-Urethroscope System KARL STORZ Endoscopy America, Inc.
K202272 08/11/2020 HD Mediastinoscope Karl Storz Endoscopy America, Inc.
K112480 08/29/2011 VIEW 1 IMAGING KARL STORZ ENDOSCOPY AMERICA, INC.
K193235 11/25/2019 Telepack + Karl Storz Endoscopy America, Inc.


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