Gyrus Acmi, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Gyrus Acmi, Inc. - FDA 510(k) Cleared Devices
Recent clearances: POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA), RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard), POWERSEAL Sealer and Divider
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.
FDA 510(k) Regulatory Record - Gyrus Acmi, Inc.
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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