# Gyrus Acmi, Inc.

- Location (FDA's records): Southborough, MA
- FDA decisions: 46 (1993–2026): 44 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Gyrus Acmi, Inc. (44); Gyrus-Acmi L.P. (1); Gyrus Acmi (1)
- Product codes: GEI (21), KCT (3), ERL (3), FAS (2), GEX (2), HIN (2), FGE (1), HIH (1), LJE (1), FGB (1), FGA (1), LYA (1)
- 510(k) review time since 2016: median 142 days, against 137 for FDA's reviews in the same codes and years (9 of 14 faster)
- Predicates its devices cite: 88 (19 its own); citations of its devices by later devices: 35 (19 its own)
- Recalls linked to its devices: 45 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gyrus Medical, Inc.: 18 (https://510kreport.com/company/gyrus-medical)
- Acmi Corporation: 6 (https://510kreport.com/company/acmi)
- Gyrus Ent LLC: 6 (https://510kreport.com/company/gyrus-ent)
- Olympus Surgical Technologies America: 4 (https://510kreport.com/company/olympus-surgical-technologies-america)
- Valleylab, Inc.: 4 (https://510kreport.com/company/valleylab)
- Boston Scientific Corp: 3 (https://510kreport.com/company/boston-scientific)
- Olympus Winter & Ibe GmbH: 3 (https://510kreport.com/company/olympus-winter-ibe)
- Olympus Optical Co., Ltd.: 2 (https://510kreport.com/company/olympus-optical)

## Firms that cite its devices most
- Olympus Winter & Ibe GmbH: 4 (https://510kreport.com/company/olympus-winter-ibe)
- Lina Medical Aps: 2 (https://510kreport.com/company/lina-medical)
- Olympus Surgical Technologies America: 2 (https://510kreport.com/company/olympus-surgical-technologies-america)
- Fem Suite, LLC: 1 (https://510kreport.com/company/fem-suite)
- Covidien Lp, Formerly Know AS Valleylab, A Divison: 1 (https://510kreport.com/company/covidien-lp-formerly-know-as-valleylab-a-divison)
- Chirurgie Innovation: 1 (https://510kreport.com/company/chirurgie-innovation)
- Olympus Keymed (Medical & Industrial Equipment) LT: 1 (https://510kreport.com/company/olympus-keymed-medical-industrial-equipment-lt)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)

## Its most-cited devices
- K092682: Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays (2009), cited by 4
- K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 (2009), cited by 3
- K100816: PK Superpulse Sysem Generator Model 744000 (2010), cited by 3
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) (2011), cited by 3
- K211401: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2021), cited by 2
- K152219: PK AIM (2015), cited by 1

## Recent decisions
- K252487: POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (Mar 2, 2026)
- K233275: 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) (Mar 25, 2024)
- K231327: POWERSEAL Sealer and Divider (Oct 25, 2023)
- K221306: SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories (Jan 27, 2023)
- K212650: Celeris, Disposable Sinus Debrider (Jan 19, 2022)
- K213831: Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (Jan 4, 2022)
- K211401: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (Jun 3, 2021)
- P180007: Spiration® Valve System (Dec 3, 2018)

Source page: https://510kreport.com/company/gyrus-acmi