# Omnisonics Medical Technologies

- Location (FDA's records): Wilmington, MA
- FDA decisions: 8 (1999–2008): 8 510(k) clearances
- Product codes: QEY (4), LFL (2), GCM (1), GCJ (1)
- Predicates its devices cite: 27 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Valleylab, Inc.: 5 (https://510kreport.com/company/valleylab)
- Galileo Electro-Optics Corp.: 2 (https://510kreport.com/company/galileo-electro-optics)
- Cooper Lasersonics, Inc.: 2 (https://510kreport.com/company/cooper-lasersonics)
- Cordis Corp.: 2 (https://510kreport.com/company/cordis)
- Arrow Intl., Inc.: 2 (https://510kreport.com/company/arrow-intl)
- Karl Storz Endoscopy: 1 (https://510kreport.com/company/karl-storz-endoscopy)
- Cardima, Inc.: 1 (https://510kreport.com/company/cardima)
- Imagyn Medical, Inc.: 1 (https://510kreport.com/company/imagyn-medical)

## Firms that cite its devices most
- Epitek, Inc.: 1 (https://510kreport.com/company/epitek)

## Its most-cited devices
- K991377: Omnisonics Flexible Fiber Optic Endoscope and Coupler (1999), cited by 2
- K052428: Resolution Endovascular System (2005), cited by 1
- K041705: Resolution Thrombectomy System, Model EV-2 (2004), cited by 1
- K071762: Omniwave Endovascular System (2007), cited by 1

## Recent decisions
- K083335: Modified Omniwave Endovascular System (Dec 15, 2008)
- K071762: Omniwave Endovascular System (Sep 27, 2007)
- K052428: Resolution Endovascular System (Dec 8, 2005)
- K041705: Resolution Thrombectomy System, Model EV-2 (Sep 1, 2004)
- K003824: Omnisonics Ultrasonic Surgery System, Model Sti (Mar 8, 2001)
- K993628: Omnisonics Ultrasonic Probes (Dec 15, 1999)
- K993445: Omnisonic Endoscopic Deflector (Dec 6, 1999)
- K991377: Omnisonics Flexible Fiber Optic Endoscope and Coupler (Jul 12, 1999)

Source page: https://510kreport.com/company/omnisonics-medical-technologies