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
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.
510(k) submissions have been managed by Gyrus Ent LLC, Sub. of Gyrus Acmi, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Gyrus Acmi, Inc.
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