# Estech, Inc.

- Location (FDA's records): Alameda, CA
- FDA decisions: 7 (1999–2013): 7 510(k) clearances
- Product codes: GEI (3), DWF (2), DXC (1), DTS (1)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 13 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- California Medical Laboratories, Inc.: 1 (https://510kreport.com/company/california-medical-laboratories)
- International Biophysics Corp.: 1 (https://510kreport.com/company/international-biophysics)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)
- Medtronic Perfusion Systems: 1 (https://510kreport.com/company/medtronic-perfusion-systems)
- Research Medical, Inc.: 1 (https://510kreport.com/company/research-medical)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Endoscopic Technologies, Inc. D/B/A Estech: 1 (https://510kreport.com/company/endoscopic-technologies-d-b-a-estech)

## Firms that cite its devices most
- Abiomed, Inc.: 2 (https://510kreport.com/company/abiomed)
- Endoscopic Technologies, Inc. D/B/A Estech: 2 (https://510kreport.com/company/endoscopic-technologies-d-b-a-estech)
- Thermopeutix, Inc.: 1 (https://510kreport.com/company/thermopeutix)
- AtriCure, Inc.: 1 (https://510kreport.com/company/atricure)
- Endoscopic Technologies, Inc.: 1 (https://510kreport.com/company/endoscopic-technologies)
- Medela AG: 1 (https://510kreport.com/company/medela)
- LivaNova USA, Inc.: 1 (https://510kreport.com/company/livanova-usa)
- Ncontact Surgical, Inc.: 1 (https://510kreport.com/company/ncontact-surgical)

## Its most-cited devices
- K051749: Cobra Surgical System (2005), cited by 5
- K990573: Estech Arterial Remote Access Perfusion Cannula (1999), cited by 3
- K052081: Remote Access Perfusion (Rap) Femoral Venous Cannula (2005), cited by 2
- K041599: Cobra Adhere Surgical System (2004), cited by 2
- K032632: Remote Access Perfusion Cannula Left Axillary 21 French (2003), cited by 1

## Recent decisions
- K133017: Estech Cobra (R) Genesis Bipolar Clamp (Oct 7, 2013)
- K053021: Estech Clearview MV Atrial Depressor (Jan 26, 2006)
- K052081: Remote Access Perfusion (Rap) Femoral Venous Cannula (Dec 16, 2005)
- K051749: Cobra Surgical System (Sep 13, 2005)
- K041599: Cobra Adhere Surgical System (Jul 27, 2004)
- K032632: Remote Access Perfusion Cannula Left Axillary 21 French (Oct 22, 2003)
- K990573: Estech Arterial Remote Access Perfusion Cannula (Mar 11, 1999)

Source page: https://510kreport.com/company/estech