Insightra Medical Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 2032677
• FEI Number: 3003945344
• Name: INSIGHTRA MEDICAL, INC.
• Owner & Operator: INSIGHTRA MEDICAL, INC.
• Contact Address: 141 Hatcher Lane ; Clarksville TN 37043 US
• Official Correspondent:
  • Wayne A Lyle
  • x-931-9192955-104
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 141 Hatcher Lane ; Clarksville, TN 37043 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 00013964672077 INSIGHTRA MEDICAL, INC.	Modulare Stabilization Device	2019-12-18
GUDID 00850012832348 INSIGHTRA MEDICAL, INC.	Freedom - Ventral Hernia Repair System FVHR35X45	2019-12-11
GUDID 00850012832256 INSIGHTRA MEDICAL, INC.	Freedom - Ventral Hernia Repair System FVHR15X25	2019-12-11
GUDID 00850012832041 INSIGHTRA MEDICAL, INC.	Freedom - ProFlor Inguinal Hernia Implant FIHR 25mmE	2019-12-11
GUDID 00837654352991 INSIGHTRA MEDICAL, INC.	Freedom - Ventral Hernia Repair System FVHR28X35	2019-12-11
GUDID 00837654352984 INSIGHTRA MEDICAL, INC.	Freedom - Ventral Hernia Repair System FVHR20X30	2019-12-11
GUDID 00837654352960 INSIGHTRA MEDICAL, INC.	Freedom - Ventral Hernia Repair System FVHR12X15	2019-12-11
GUDID 00837654076439 INSIGHTRA MEDICAL, INC.	Ultra IABP Catheter Kit	2019-12-11
GUDID 00837654076415 INSIGHTRA MEDICAL, INC.	Ultra IABP Catheter Kit	2019-12-11
GUDID 00837654070956 INSIGHTRA MEDICAL, INC.	Ultra IABP Catheter Kit	2019-12-11
GUDID 00013964672381 INSIGHTRA MEDICAL, INC.	Freedom - ProFlor Inguinal Hernia Implant FIHR 40mm	2019-12-11
GUDID 00013964672374 INSIGHTRA MEDICAL, INC.	Freedom - ProFlor Inguinal Hernia Implant FIHR 25mm	2019-12-11
GUDID 00013964672176 INSIGHTRA MEDICAL, INC.	Freedom - ProFlor Inguinal Hernia Implant FIHR 40mmE	2019-12-11
GUDID 00837654352885 INSIGHTRA MEDICAL, INC.	Freedom - ProFlor Inguinal Hernia Kit FIHR 40mmK	2019-12-06
GUDID 00837654352878 INSIGHTRA MEDICAL, INC.	Freedom - ProFlor Inguinal Hernia Kit FIHR 25mmK	2019-12-06
GUDID 00013964672367 INSIGHTRA MEDICAL, INC.	Freedom - ProFlor Inguinal Hernia Kit FIHR 25mmEK	2019-12-06
GUDID 00013964672275 INSIGHTRA MEDICAL, INC.	Modulare Stabilization Device	2019-12-06
GUDID 00013964672152 INSIGHTRA MEDICAL, INC.	Freedom - ProFlor Inguinal Hernia Kit FIHR 40mmEK	2019-12-06
FHN INSIGHTRA MEDICAL, INC.	GIRO	2016-03-25
PMN K142192 | OXJ INSIGHTRA MEDICAL, INC.	Freedom Octomesh Ventral Hernia Repair System	2015-05-08
PMN K142192 | FTL INSIGHTRA MEDICAL, INC.	Freedom Octomesh Ventral Hernia Repair System	2015-05-08
PMN K140967 | FTL INSIGHTRA MEDICAL, INC.	ProFlor Extended Disk FIHR 40MMEK	2014-07-10
KMK INSIGHTRA MEDICAL, INC.	Modulare Stabilization Device	2014-01-06
PMN K113552 | FTL INSIGHTRA MEDICAL, INC.	Freedom Inguinal Hernia Implant	2012-11-05
MDM INSIGHTRA MEDICAL, INC.	Inguinal Hernia Delivery Instrument Set	2009-12-12
MDM INSIGHTRA MEDICAL, INC.	Freedom Inguinal Hernia Dilator	2009-12-12
PMN K082746 | DSP INSIGHTRA MEDICAL, INC.	Ultra IABP Catheter Kit	2009-02-18
PMN K082746 INSIGHTRA MEDICAL, INC.	ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20	2009-01-12

Related Finance Registrations

NCAGE Code	53QV3	INSIGHTRA MEDICAL, INC.
CAGE Code	53QV3	INSIGHTRA MEDICAL, INC.
SEC	0001606764	Insightra Medical, Inc. of CALIFORNIA