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Olympus Surgical Technologies America

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262877 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)GEX2026-09-16 View
510(k) K261221 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)GEX2026-07-24 View
510(k) K242191 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)GEX2024-08-23 View
510(k) K212643 POWERSEAL Curved Jaw Sealer and Divider, Double ActionGEI2021-09-27 View
510(k) K193517 ViziShot 2 FLEXKTI2020-03-18 View
510(k) K183647 SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)GEX2019-08-09 View
510(k) K190164 CleverLock Guidewire Locking Device and Biopsy CapODC2019-04-04 View
510(k) K181193 PeriView FLEXKTI2018-07-03 View
510(k) K171232 PeriView FLEXKTI2017-09-21 View
510(k) K163469 ViziShot 2 FLEXKTI2017-04-06 View
510(k) K132181 GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETEREZN2013-10-21 View
510(k) K123170 VARI-PASS VARIABLE LENGTH ACCESS SHEATHKNY2013-02-04 View
510(k) K123319 GYRUS ACMI BICOAG HEMOSTASIS PROBEKNS2012-12-14 View
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