Medical Device Manufacturer · US , Westborough , MA

Gyrus Acmi, Inc.

42 submissions · 42 cleared · Since 2007
42
Total
42
Cleared
0
Denied

Gyrus Acmi, Inc. — FDA 510(k) Submissions

Gyrus Acmi, Inc. has submitted 42 FDA 510(k) premarket notifications since 2007, of which 42 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Powered Laser Surgical Instrument, Electrode, Electrosurgical, Active, Urological . Use the specialty filter in the sidebar to narrow results.

42 devices
1–25 of 42
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
K252487 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2026 207d
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 · FGB Ureteroscope And... · Gastroenterology & Urology
Mar 2024 178d
POWERSEAL Sealer and Divider
K231327 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2023 170d
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
K221306 · GEX Powered Laser Surgical... · Gastroenterology & Urology
Jan 2023 267d
Celeris, Disposable Sinus Debrider
K212650 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Jan 2022 149d
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
K213831 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2022 27d
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
K211401 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jun 2021 28d
ChitoZolve
K181696 · LYA Splint, Intranasal Septal · Ear, Nose, Throat
Nov 2018 156d
Gyrus ACMI ? EZDilate 3-Stage Balloon Dilatation Catheter
K180086 · FGE Stents, Drains And... · Gastroenterology & Urology
Mar 2018 55d
PK AIM
K170908 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2017 52d
PK AIM
K163373 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2016 11d
PK Morcellator
K161038 · GEI Electrosurgical, Cutting... · Obstetrics & Gynecology
Oct 2016 177d
PK AIM
K161825 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2016 87d
DIEGO ELITE DRILL
K152744 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Jun 2016 261d
InstaClear Lens Cleaner
K152531 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Jan 2016 134d
PK AIM
K152219 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2015 132d
PK Cutting Forceps for ESG-400 Workstation
K142759 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2015 110d
PK J-HOOK
K142350 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2015 139d
PK Spatula
K142289 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2014 135d
PK NEEDLE
K142154 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2014 135d
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
K132383 · LJE Catheter, Nephrostomy · Gastroenterology & Urology
Feb 2014 188d
OLYMPUS ENERGY POWER SYSTEM (EPS)
K123429 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2013 149d
PKS BILL
K122605 · HIN Coagulator-cutter,... · Obstetrics & Gynecology
Dec 2012 100d
DTAD
K121678 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Aug 2012 84d
GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
K120474 · KCT Sterilization Wrap... · General Hospital
Jul 2012 145d
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