FDA 510(k) Applications Submitted by JAMES A LEE

FDA 510(k) Number Submission Date Device Name Applicant
K061180 04/27/2006 KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR KARL STORZ ENDOSCOPY-AMERICA, INC.
K041473 06/02/2004 VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM VORTRAN MEDICAL TECHNOLOGY 1, INC.
K182292 08/23/2018 VORTRAN APM-Plus VORTRAN Medical Technology 1, Inc.
K162968 10/24/2016 VORTRAN GO2VENT VORTRAN MEDICAL TECHNOLOGY 1, INC.
K073261 11/20/2007 VAR MONITOR VORTRAN MEDICAL TECHNOLOGY 1, INC.
K103639 12/13/2010 VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC VORTRAN MEDICAL TECHNOLOGY 1, INC.
K173914 12/22/2017 VORTRAN Cuff Inflator (VCI) VORTRAN Medical Technology 1, Inc.
K153733 12/28/2015 VORTRAN Manometer VORTRAN MEDICAL TECHNOLOGY 1, INC.
K010345 02/05/2001 KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS KARL STORZ ENDOSCOPY-AMERICA, INC.
K010346 02/05/2001 KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR KARL STORZ ENDOSCOPY-AMERICA, INC.
K020599 02/22/2002 MTP CLEARVISION DISPOSABLE TUBING SET MTP MEDICAL TECHNICAL PROMOTION GMBH
K010569 02/26/2001 KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP KARL STORZ ENDOSCOPY
K020640 02/27/2002 KSEA SCB MEDIA CONTROL KARL STORZ ENDOSCOPY-AMERICA, INC.
K010785 03/15/2001 KSEA DION-GRACIA SET KARL STORZ ENDOSCOPY-AMERICA, INC.
K021050 04/01/2002 KSEA NEUROENDOSCOPES AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC.
K010987 04/02/2001 KSEA MINIATURE TELESCOPE AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC.
K011359 05/03/2001 MODIFICATION TO KSEA ENDOTIP SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.
K011360 05/03/2001 MTP LAPAROMAT DISPOSABLE TUBING SET MTP MEDICAL TECHNICAL PROMOTION GMBH
K021467 05/07/2002 AUTOCON II 400 ELECTROSURGICAL GENERATOR KARL STORZ ENDOSCOPY-AMERICA, INC.
K021776 05/29/2002 KSEA QUADRO SWITCH KARL STORZ ENDOSCOPY
K021811 06/03/2002 UNIDRIVE II PLUS DISPOSABLE TUBING SET MTP MEDICAL TECHNICAL PROMOTION GMBH
K061541 06/05/2006 KSEA BIPOLAR ELECTROTOME KSEA
K011793 06/08/2001 KSEA FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.
K011841 06/12/2001 KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR KARL STORZ ENDOSCOPY
K031895 06/19/2003 KSEA OPSERVER LAP KARL STORZ ENDOSCOPY-AMERICA, INC.
K022490 07/29/2002 KSEA MEDI PACK KARL STORZ ENDOSCOPY-AMERICA, INC.
K012527 08/06/2001 KSEA SIALOENDOSCOPES AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC.
K062464 08/24/2006 MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR KARL STORZ ENDOSCOPY-AMERICA, INC.
K022853 08/27/2002 ENDOTACK KARL STORZ ENDOSCOPY-AMERICA, INC.
K013107 09/17/2001 BIOABSORBABLE INTERFERENCE SCREW MEGAFIX KARL STORZ ENDOSCOPY
K023187 09/24/2002 KSEA SPINOSCOPE KARL STORZ ENDOSCOPY
K023704 11/04/2002 KSEA SCB ACC CONTROL KARL STORZ ENDOSCOPY-AMERICA, INC.
K013838 11/19/2001 KSEA CLEARVISION LENS IRRIGATION SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.
K023924 11/25/2002 AUTOCON II 200 ELECTROSURGICAL GENERATOR KARL STORZ ENDOSCOPY
K003994 12/26/2000 KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC.
K014277 12/27/2001 KSEA DEPLOYABLE CARDIOVASCULAR CLAMP KARL STORZ ENDOSCOPY-AMERICA, INC.


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