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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