Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ESTECH HAWKEYE INTRODUCER SYSTEMS

K-Number: K091350 · 2009-09-15

ApplicantEndoscopic Technologies, Inc. D/B/A Estech
Decision Date2009-09-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ESTECH HAWKEYE INTRODUCER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. It received FDA 510(k) clearance on 2009-09-15 under 510(k) number K091350. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTECH HAWKEYE INTRODUCER SYSTEMS?

ESTECH HAWKEYE INTRODUCER SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-09-15. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. The 510(k) number is K091350.

When did ESTECH HAWKEYE INTRODUCER SYSTEMS receive FDA 510(k) clearance?

ESTECH HAWKEYE INTRODUCER SYSTEMS received FDA 510(k) clearance on 2009-09-15, under 510(k) number K091350.

Who is the listed applicant for ESTECH HAWKEYE INTRODUCER SYSTEMS?

The FDA 510(k) record lists Endoscopic Technologies, Inc. D/B/A Estech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTECH HAWKEYE INTRODUCER SYSTEMS?

The FDA product code for ESTECH HAWKEYE INTRODUCER SYSTEMS is GCJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Endoscopic Technologies, Inc. D/B/A Estech as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113475ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEMK110913ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORYK100224ESTECH COBRA BIPOLSR IIK091542ESTECH EASYFLOW CANNULA WITH GUIDEWIRE

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑