Ergosurg

FDA Filings

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

FDA Registration(s)

• Registration Number: 3010020902
• FEI Number: 3010020902
• Name: Susie S. Chen
• Owner & Operator: Ergosurg
• Contact Address: Gleissenweg 1 ; Ismaning DE-BY Bayern 85737 DE
• US Agent:
  • Susie S. Chen
  • KARL STORZ ENDOSCOPY-AMERICA, INC.
  • 424 2188201
  • 424 2188519
  • Su.chen@Karlstorz.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2151 E Grand Avenue ; El Segundo, CA 90245 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K161555 | PGW Susie S. Chen [Ergosurg]	NAV1 Electromagnetic Navigation System	2017-12-20
PMN K122096 | HAW Susie S. Chen [Ergosurg]	Navigation Panel Unit	2017-12-20
PMN K122096 | HAW Susie S. Chen [Ergosurg]	NAV1 Optical Navigation System	2017-12-20