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Gyrus Acmi, Inc.

42 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (K252487)Gyrus Acmi, Inc.2026-03-02
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) (K233275)Gyrus Acmi, Inc.2024-03-25
POWERSEAL Sealer and Divider (K231327)Gyrus Acmi, Inc.2023-10-25
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories (K221306)Gyrus Acmi, Inc.2023-01-27
Celeris, Disposable Sinus Debrider (K212650)Gyrus Acmi, Inc.2022-01-19
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (K213831)Gyrus Acmi, Inc.2022-01-04
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K211401)Gyrus Acmi, Inc.2021-06-03
ChitoZolve (K181696)Gyrus Acmi, Inc.2018-11-30
Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (K180086)Gyrus Acmi, Inc.2018-03-08
PK AIM (K170908)Gyrus Acmi, Inc.2017-05-19
PK AIM (K163373)Gyrus Acmi, Inc.2016-12-12
PK Morcellator (K161038)Gyrus Acmi, Inc.2016-10-07
PK AIM (K161825)Gyrus Acmi, Inc.2016-09-26
DIEGO ELITE DRILL (K152744)Gyrus Acmi, Inc.2016-06-10
InstaClear Lens Cleaner (K152531)Gyrus Acmi, Inc.2016-01-15
PK AIM (K152219)Gyrus Acmi, Inc.2015-12-17
PK Cutting Forceps for ESG-400 Workstation (K142759)Gyrus Acmi, Inc.2015-01-13
PK J-HOOK (K142350)Gyrus Acmi, Inc.2015-01-08
PK Spatula (K142289)Gyrus Acmi, Inc.2014-12-31
PK NEEDLE (K142154)Gyrus Acmi, Inc.2014-12-19
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER (K132383)Gyrus Acmi, Inc.2014-02-04
OLYMPUS ENERGY POWER SYSTEM (EPS) (K123429)Gyrus Acmi, Inc.2013-04-05
PKS BILL (K122605)Gyrus Acmi, Inc.2012-12-05
DTAD (K121678)Gyrus Acmi, Inc.2012-08-30
GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY (K120474)Gyrus Acmi, Inc.2012-07-10
GYRUS AMCI PK BUTTON ELECTRODE (K120567)Gyrus Acmi, Inc.2012-06-20
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (K111059)Gyrus Acmi, Inc.2011-09-01
DOLPHIN 3 FLUID MANAGEMENT SYSTEM (K110852)Gyrus Acmi, Inc.2011-07-19
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT (K102970)Gyrus Acmi, Inc.2011-05-20
GYRUS ACMI BIOCOAG PROBE (K092571)Gyrus Acmi, Inc.2010-10-20
PK SUPERPULSE SYSEM GENERATOR MODEL 744000 (K100816)Gyrus Acmi, Inc.2010-07-01
GYRUS ACMI HALO PKS CUTTING FORCEPS (K100896)Gyrus Acmi, Inc.2010-06-17
GYRUS ACMI PK BUTTON ELECTRODE (K093181)Gyrus Acmi, Inc.2010-02-24
GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS (K092682)Gyrus Acmi, Inc.2009-12-11
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 (K092278)Gyrus Acmi, Inc.2009-09-29
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE (K080844)Gyrus Acmi, Inc.2009-08-13
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (K090814)Gyrus Acmi, Inc.2009-04-20
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 (K083013)Gyrus Acmi, Inc.2008-12-09
GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 (K082054)Gyrus Acmi, Inc.2008-08-06
GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE (K081954)Gyrus Acmi, Inc.2008-07-31
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK (K080093)Gyrus Acmi, Inc.2008-05-02
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (K072594)Gyrus Acmi, Inc.2007-12-13

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