FDA 510(k) Applications Submitted by Graham A. L. Baillie
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K083013 |
10/09/2008 |
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 |
GYRUS ACMI, INC. |
| K020301 |
01/29/2002 |
MODIFICATION TO VISTA STEREOSCOPE SYSTEM |
VISTA MEDICAL TECHNOLOGIES, INC. |
| K040628 |
03/10/2004 |
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM |
ABBOTT LABORATORIES |
| K110852 |
03/28/2011 |
DOLPHIN 3 FLUID MANAGEMENT SYSTEM |
GYRUS ACMI, INC. |
| K021290 |
04/23/2002 |
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 |
VISTA MEDICAL TECHNOLOGIES, INC. |
| K051593 |
06/16/2005 |
UROPASS URETERAL ACCESS SHEATH, MODEL 61224 |
ACMI CORPORATION |
| K132703 |
08/29/2013 |
THUNDERBEAT |
OLYMPUS MEDICAL SYSTEMS CORP. |
| K964037 |
10/08/1996 |
FLEXIBLE CYSTOSCOPE |
APPLIED FIBEROPTICS, INC. |
| K964482 |
11/08/1996 |
FLEXIBLE URETEROSCOPE |
APPLIED FIBEROPTICS, INC. |
| K043581 |
12/28/2004 |
DUAL LUMEN CATHETER |
ACMI CORPORATION |
| K072594 |
09/14/2007 |
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM |
GYRUS ACMI, INC. |
| K141225 |
05/12/2014 |
ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD |
OLYMPUS WINTER & IBE GMBH |
| K170908 |
03/28/2017 |
PK AIM |
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. |
| K161825 |
07/01/2016 |
PK AIM |
GYRUS ACMI INC. |
| K142525 |
09/08/2014 |
PK Lap Loop |
Olympus Winter & Ibe GmbH |
| K163373 |
12/01/2016 |
PK AIM |
Gyrus ACMI Inc. |
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