Gordian Surgical

FDA Filings

This page includes the latest FDA filings for Gordian Surgical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011803381
• FEI Number: 3011803381
• Name: GORDIAN SURGICAL
• Owner & Operator: Gordian Surgical
• Contact Address: 17 Tchelet Street Misgav Business Park; M.P. Misgav IL-Z Ha Zafon 2017400 IL
• Official Correspondent:
  • AVIAD Dotan
  • 972-72-2607016-x
• US Agent:
  • Susan Alpert
  • SFA Regulatory c/o
  • 613 2027019
  • Drsusanalpert@gmail.com
• Importing Logistics Registration:
  • Importer: Gordian Surgical Inc.
  • Address: One Penn Plaza, Suite 2527 c/o Shiboleth LLP ; Manhattan, NY 10119 UNITED STATES
  • Email Address: GordianUSA@GordianSurgical.com
  • Phone: 1 619 4673426
• Importing Logistics Registration:
  • Importer: Med-Tech Consultant Partners, LLC
  • Address: 9 Hawthorne Lane ; Great Neck, NY 11023 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 17 Tchelet Street Misgav Business Park; M.P. Misgav Ha Zafon, 2017400 IL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K171494 | GCJ GORDIAN SURGICAL	TroClose1200	2017-09-13
PMN K171494 | GCJ GORDIAN SURGICAL	TroClose1200 Cannula	2017-09-13
PMN K171494 | GAM GORDIAN SURGICAL	TroClose1200	2017-09-13
PMN K171494 | GAM GORDIAN SURGICAL	TroClose1200 Cannula	2017-09-13
PMN K160564 | GCJ GORDIAN SURGICAL	TroClose1200	2016-12-15
PMN K160564 | GCJ GORDIAN SURGICAL	TroClose1200 Cannula	2016-12-15
PMN K160564 | GAM GORDIAN SURGICAL	TroClose1200	2016-12-15
PMN K160564 | GAM GORDIAN SURGICAL	TroClose1200 Cannula	2016-12-15

Similar & Related FDA Registered Companies

• Gordian Surgical Inc.
• Gordian Surgical Ltd.