Clearance Summary
ESTECH HAWKEYE INTRODUCER SYSTEMS received FDA 510(k) clearance under submission number K091350, sponsored by Endoscopic Technologies, Inc. D/B/A Estech. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2009-09-15.
- Submission: K091350
- Applicant / Sponsor: Endoscopic Technologies, Inc. D/B/A Estech
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2009-09-15
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.