Gyrus Acmi, Inc. - FDA 510(k) Cleared Devices

Cleared Mar 02, 2026

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)

K252487 · GEI

General & Plastic Surgery · 207d

Cleared Oct 25, 2023

POWERSEAL Sealer and Divider

K231327 · GEI

General & Plastic Surgery · 170d

Cleared Jan 04, 2022

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

K213831 · GEI

General & Plastic Surgery · 27d

Cleared Jun 03, 2021

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium...

K211401 · GEX

General & Plastic Surgery · 28d

Cleared May 19, 2017

PK AIM

K170908 · GEI

General & Plastic Surgery · 52d

Cleared Dec 12, 2016

PK AIM

K163373 · GEI

General & Plastic Surgery · 11d

Cleared Sep 26, 2016

PK AIM

K161825 · GEI

General & Plastic Surgery · 87d

Cleared Dec 17, 2015

PK AIM

K152219 · GEI

General & Plastic Surgery · 132d

Cleared Jan 13, 2015

PK Cutting Forceps for ESG-400 Workstation

K142759 · GEI

General & Plastic Surgery · 110d

Cleared Jan 08, 2015

PK J-HOOK

K142350 · GEI

General & Plastic Surgery · 139d

Cleared Dec 31, 2014

PK Spatula

K142289 · GEI

General & Plastic Surgery · 135d

Cleared Dec 19, 2014

PK NEEDLE

K142154 · GEI

General & Plastic Surgery · 135d