|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
powerseal sealer and divider
|
Gyrus ACMI, Inc.
|
K231327 |
10/25/2023
|
pks plasma morcellator, models 962000pk, 3620pk
|
GYRUS ACMI, INC.
|
K080093 |
05/02/2008
|
pk superpulse sysem generator model 744000
|
GYRUS ACMI, INC.
|
K100816 |
07/01/2010
|
pk needle
|
GYRUS ACMI, INC.
|
K142154 |
12/19/2014
|
pk morcellator
|
GYRUS ACMI, INC.
|
K161038 |
10/07/2016
|
pk diego powered dissector console, model 7033-9050, diego trigger-enabled powered dissector handpiece, model 7033-9001
|
GYRUS ACMI, INC.
|
K083013 |
12/09/2008
|
pk cutting forceps for esg-400 workstation
|
GYRUS ACMI, INC.
|
K142759 |
01/13/2015
|
olympus pk electrosurgical instruments, pk j-hook, pk spatula, pk needle
|
Gyrus ACMI, Inc.
|
K213831 |
01/04/2022
|
olympus energy power system (eps)
|
GYRUS ACMI, INC.
|
K123429 |
04/05/2013
|
gyrus amci pk button electrode
|
GYRUS ACMI, INC.
|
K120567 |
06/20/2012
|
|