Gyrus Acmi, Inc. - FDA 510(k) Cleared Devices
42
Total
42
Cleared
0
Denied
Gyrus Acmi, Inc. has 42 FDA 510(k) cleared medical devices. Based in Westborough, US.
Latest FDA clearance: Mar 2026. Active since 2007. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Gyrus Acmi, Inc. Filter by specialty or product code using the sidebar.
42 devices
Cleared
Mar 02, 2026
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
General & Plastic Surgery
207d
Cleared
Mar 25, 2024
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard)
Gastroenterology & Urology
178d
Cleared
Oct 25, 2023
POWERSEAL Sealer and Divider
General & Plastic Surgery
170d
Cleared
Jan 27, 2023
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE...
Gastroenterology & Urology
267d
Cleared
Jan 19, 2022
Celeris, Disposable Sinus Debrider
Ear, Nose, Throat
149d
Cleared
Jan 04, 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
General & Plastic Surgery
27d
Cleared
Jun 03, 2021
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium...
General & Plastic Surgery
28d
Cleared
Nov 30, 2018
ChitoZolve
Ear, Nose, Throat
156d
Cleared
Mar 08, 2018
Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
Gastroenterology & Urology
55d
Cleared
May 19, 2017
PK AIM
General & Plastic Surgery
52d
Cleared
Dec 12, 2016
PK AIM
General & Plastic Surgery
11d
Cleared
Oct 07, 2016
PK Morcellator
Obstetrics & Gynecology
177d
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