FDA 510(k) Applications Submitted by Olympus Surgical Technologies America

FDA 510(k) Number Submission Date Device Name Applicant
K212643 08/20/2021 POWERSEAL Curved Jaw Sealer and Divider, Double Action Olympus Surgical Technologies America
K123170 10/09/2012 VARI-PASS VARIABLE LENGTH ACCESS SHEATH OLYMPUS SURGICAL TECHNOLOGIES AMERICA
K183647 12/26/2018 SOLTIVEÖ Laser System(SOLTIVEÖ Pro SuperPulsed Laser, SOLTIVEÖ Premium SuperPulsed Laser, SOLTIVEÖLaser Fibers, and Accessories) Olympus Surgical Technologies America
K190164 01/31/2019 CleverLock Guidewire Locking Device and Biopsy Cap Olympus Surgical Technologies America
K171232 04/27/2017 PeriView FLEX Olympus Surgical Technologies America
K181193 05/04/2018 PeriView FLEX Olympus Surgical Technologies America
K163469 12/12/2016 ViziShot 2 FLEX Olympus Surgical Technologies America
K143609 12/19/2014 Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter OLYMPUS SURGICAL TECHNOLOGIES AMERICA
K193517 12/19/2019 ViziShot 2 FLEX Olympus Surgical Technologies America
K132181 07/15/2013 GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER OLYMPUS SURGICAL TECHNOLOGIES AMERICA
K123319 10/26/2012 GYRUS ACMI BICOAG HEMOSTASIS PROBE OLYMPUS SURGICAL TECHNOLOGIES AMERICA


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