FDA 510(k) Applications Submitted by WINKIE WONG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K140964 |
04/15/2014 |
CALCULASE II |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K201001 |
04/16/2020 |
Modulith SLX-F2 |
KARL STORZ Endoscopy America |
| 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. |
| K171238 |
04/27/2017 |
KARL STORZ ICG Imaging System |
Karl Storz Endoscopy- America, Inc. |
| K101215 |
04/30/2010 |
NUANCE |
DISCUS DENTAL, LLC |
| K101612 |
06/09/2010 |
ZEN CORDLESS PROPHY SYSTEM |
DISCUS DENTAL, LLC |
| K131953 |
06/27/2013 |
IMAGE1 SPIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K111997 |
07/13/2011 |
IMAGE1 GI CCU MODEL 22203020-114 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K212476 |
08/06/2021 |
KARL STORZ Flexible HD Cysto-Urethroscope System |
KARL STORZ Endoscopy America, Inc. |
| K092417 |
08/07/2009 |
INSIGHT ULTRASONIC INSERTS |
DISCUS DENTAL, LLC |
| K202272 |
08/11/2020 |
HD Mediastinoscope |
Karl Storz Endoscopy America, Inc. |
| K112480 |
08/29/2011 |
VIEW 1 IMAGING |
KARL STORZ ENDOSCOPY AMERICA, INC. |
| K162410 |
08/29/2016 |
TIPCAM 1S 3D System |
KARL STORZ Endoscopy America, Inc |
| K122983 |
09/26/2012 |
KSEA BIPOLAR ELECTRODE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K182696 |
09/27/2018 |
Telepack X LED |
KARL STORZ Endoscopy-America, Inc |
| K202957 |
09/30/2020 |
Flexible Video Cysto-Urethroscope (C-view) |
KARL STORZ Endoscopy-America, Inc |
| K162880 |
10/14/2016 |
TIPCAM 1S 3D System |
KARL STORZ Endoscopy America, Inc |
| K193235 |
11/25/2019 |
Telepack + |
Karl Storz Endoscopy America, Inc. |
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