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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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