# K091350: Estech Hawkeye Introducer Systems

- Pathway: 510(k) (Traditional)
- Applicant: Endoscopic Technologies, Inc. D/B/A Estech
- Decided: Sep 15, 2009 after 131 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945975 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062050: Flexview System, Boston Scientific (2006) Summary page 1.

## Indications for use
The HawkeyeTM Introducer Systems, and accessories, are intended for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., ESTECH COBRA Adhere XL, AFfirm Pacing Probe). They are indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.

Source page: https://510kreport.com/device/K091350
Methodology: https://510kreport.com/methodology