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Gyrus Acmi, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories9
Latest FDA decision2026-05-07
TypeNumberDevice NameCodeDateActions
PMA P180007 Valve, pulmonaryNJK2026-05-07 View
510(k) K252487 POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)GEI2026-03-02 View
510(k) K233275 RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)FGB2024-03-25 View
510(k) K231327 POWERSEAL Sealer and DividerGEI2023-10-25 View
510(k) K221306 SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesGEX2023-01-27 View
510(k) K212650 Celeris, Disposable Sinus DebriderERL2022-01-19 View
510(k) K213831 Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGEI2022-01-04 View
510(k) K211401 SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)GEX2021-06-03 View
PMA P870076 Laparoscopic contraceptive tubal occlusion deviceKNH2021-05-19 View
510(k) K181696 ChitoZolveLYA2018-11-30 View
510(k) K180086 Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterFGE2018-03-08 View
510(k) K170908 PK AIMGEI2017-05-19 View
510(k) K163373 PK AIMGEI2016-12-12 View
510(k) K161038 PK MorcellatorGEI2016-10-07 View
510(k) K161825 PK AIMGEI2016-09-26 View
510(k) K152744 DIEGO ELITE DRILLERL2016-06-10 View
510(k) K152531 InstaClear Lens CleanerEOB2016-01-15 View
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