Medical Device Manufacturer · US , Mountain View , CA

Surgrx, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2003

Recent clearances: ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL, ENSEAL TISSUE SEALING DEVICE, ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM

View 12 510(k) Devices ↓
12
Total
12
Cleared
0
Denied

FDA 510(k) Regulatory Record - Surgrx, Inc. General & Plastic Surgery ✕

12 devices
1-12 of 12
Cleared Jul 28, 2008
ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD,...
K081129 · GEI
General & Plastic Surgery · 98d
Cleared Sep 27, 2007
ENSEAL TISSUE SEALING DEVICE
K072493 · GEI
General & Plastic Surgery · 22d
Cleared Sep 05, 2007
ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM
K072177 · GEI
General & Plastic Surgery · 30d
Cleared Jul 13, 2007
MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE
K071728 · GEI
General & Plastic Surgery · 18d
Cleared Apr 24, 2007
ENSEAL PTC TISSUE SEALING DEVICE
K070896 · GEI
General & Plastic Surgery · 22d
Cleared Jan 29, 2007
ENSEAL PTC TRIO
K070165 · GEI
General & Plastic Surgery · 11d
Cleared Oct 18, 2006
ENSEAL PTC TISSUE SEATING SEALING DEVICE
K062949 · GEI
General & Plastic Surgery · 19d
Cleared Oct 18, 2006
ENSEAL PTC TISSUE SEALING DEVICE
K063097 · GEI
General & Plastic Surgery · 8d
Cleared Jun 15, 2006
ENSEAL PTC TISSUE SEALING DEVICE
K061526 · GEI
General & Plastic Surgery · 13d
Cleared Apr 01, 2005
ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
K050671 · GEI
General & Plastic Surgery · 17d
Cleared Nov 17, 2004
SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
K043008 · GEI
General & Plastic Surgery · 16d
Cleared Jul 03, 2003
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL...
K031133 · GEI
General & Plastic Surgery · 85d
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