FDA 510(k) Applications Submitted by Gyrus ACMI, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K121678 |
06/07/2012 |
DTAD |
GYRUS ACMI, INC. |
| K212650 |
08/23/2021 |
Celeris, Disposable Sinus Debrider |
Gyrus ACMI, Inc. |
| K152531 |
09/03/2015 |
InstaClear Lens Cleaner |
GYRUS ACMI, INC. |
| K142759 |
09/25/2014 |
PK Cutting Forceps for ESG-400 Workstation |
GYRUS ACMI, INC. |
| K123429 |
11/07/2012 |
OLYMPUS ENERGY POWER SYSTEM (EPS) |
GYRUS ACMI, INC. |
| K213831 |
12/08/2021 |
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle |
Gyrus ACMI, Inc. |
| K083013 |
10/09/2008 |
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 |
GYRUS ACMI, INC. |
| K120474 |
02/16/2012 |
GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY |
GYRUS ACMI, INC. |
| K110852 |
03/28/2011 |
DOLPHIN 3 FLUID MANAGEMENT SYSTEM |
GYRUS ACMI, INC. |
| K072594 |
09/14/2007 |
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM |
GYRUS ACMI, INC. |
| K100816 |
03/23/2010 |
PK SUPERPULSE SYSEM GENERATOR MODEL 744000 |
GYRUS ACMI, INC. |
| K090814 |
03/25/2009 |
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 |
GYRUS ACMI, INC. |
| K092278 |
07/28/2009 |
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 |
GYRUS ACMI, INC. |
| K093181 |
10/08/2009 |
GYRUS ACMI PK BUTTON ELECTRODE |
GYRUS ACMI, INC. |
| K161038 |
04/13/2016 |
PK Morcellator |
GYRUS ACMI, INC. |
| K221306 |
05/05/2022 |
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories |
Gyrus ACMI, Inc. |
| K211401 |
05/06/2021 |
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) |
Gyrus ACMI, Inc. |
| K080844 |
03/26/2008 |
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE |
GYRUS ACMI, INC. |
| K100896 |
03/31/2010 |
GYRUS ACMI HALO PKS CUTTING FORCEPS |
GYRUS ACMI, INC. |
| K111059 |
04/18/2011 |
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) |
GYRUS ACMI, INC. |
| K092571 |
08/21/2009 |
GYRUS ACMI BIOCOAG PROBE |
GYRUS ACMI, INC. |
| K092682 |
09/01/2009 |
GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS |
GYRUS ACMI, INC. |
| K102970 |
10/06/2010 |
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT |
GYRUS ACMI, INC. |
| K180086 |
01/12/2018 |
Gyrus ACMI û EZDilate 3-Stage Balloon Dilatation Catheter |
Gyrus ACMI, Inc. |
| K120567 |
02/27/2012 |
GYRUS AMCI PK BUTTON ELECTRODE |
GYRUS ACMI, INC. |
| K132383 |
07/31/2013 |
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER |
GYRUS ACMI, INC. |
| K142154 |
08/06/2014 |
PK NEEDLE |
GYRUS ACMI, INC. |
| K122605 |
08/27/2012 |
PKS BILL |
GYRUS ACMI, INC. |
| K080093 |
01/14/2008 |
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK |
GYRUS ACMI, INC. |
| K081954 |
07/09/2008 |
GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE |
GYRUS ACMI, INC. |
| K082054 |
07/21/2008 |
GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 |
GYRUS ACMI, INC. |
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