Laparoscopic FMsealer
DOMAIN SURGICAL, INC.
DOMAIN SURGICAL, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008772053 | 3008772053 | DOMAIN SURGICAL, INC. | 1 | N | 2020-04-25 | 1370 S 2100 E Salt Lake City UT US 84108 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 135789 | 1331327896 | K142229 | Laparoscopic FMsealer | GEI | 2015-01-02 |
| 135789 | 1307650575 | K141484 | OPEN FMSEALER | GEI | 2014-07-30 |
| 135789 | 1982588085 | K140384 | FMWAND HANDPIECE SE | GEI | 2014-05-23 |
| 135789 | 1481093543 | K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | HGI | 2014-01-03 |
| 135789 | 1607578183 | K121881 | DOMAIN SURGICAL SYSTEM | HGI | 2012-10-18 |
| 135789 | 1436877881 | K110439 | DOMAIN SURGICAL SYSTEM | GEI | 2011-07-18 |
Product Codes Associated With Registrations#
PMN#
OPEN FMSEALER
DOMAIN SURGICAL, INC.
FMWAND HANDPIECE SE
DOMAIN SURGICAL, INC.
FMWAND FERROMAGNETIC SURGICAL SYSTEM
DOMAIN SURGICAL, INC.
DOMAIN SURGICAL SYSTEM
DOMAIN SURGICAL, INC.
DOMAIN SURGICAL SYSTEM
DOMAIN SURGICAL, INC.
GUDID#
FMwand - FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop
2016-06-08
FMwand - FMwand Handpiece - 100 mm Length with 5 mm Resecting Loop
2016-06-09
FMwand - FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop
2016-06-10
FMwand - FMwand Handpiece - 150 mm Length with 2 mm Dissecting Loop
2016-06-09
FMwand - FMwand Handpiece - 150 mm Length with 5 mm Resecting Loop
2016-06-09
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Loop
2016-06-10
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 5 mm Resecting Loop
2016-06-10
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Blade
2016-06-10
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Loop
2016-06-10
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 5 mm Resecting Loop
2016-06-10
FMsealer - FMsealer Open Shears
2016-06-15
FMsealer - FMsealer Laparoscopic Shears - 5 mm Diameter / 36 cm Length
2016-09-22
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Blade
2016-09-22
FMX - FMX G1 Generator
2016-06-08
FMX - FMX Disposable Power Module
2016-06-08
FMX - FMX Reusable Power Module
2016-06-08
FMX - FMX G1 Generator Foot Pedal
2016-06-08
FMwand - FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop
2016-06-08
FMwand - FMwand Handpiece - 100 mm Length with 5 mm Resecting Loop
2016-06-09
FMwand - FMwand Handpiece - 100 mm Length with 2 mm Dissecting Loop
2016-06-10
FMwand - FMwand Handpiece - 150 mm Length with 2 mm Dissecting Loop
2016-06-09
FMwand - FMwand Handpiece - 150 mm Length with 5 mm Resecting Loop
2016-06-09
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Loop
2016-06-10
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 5 mm Resecting Loop
2016-06-10
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 100 mm Length with 2 mm Dissecting Blade
2016-06-10
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Loop
2016-06-10
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 5 mm Resecting Loop
2016-06-10
FMsealer - FMsealer Laparoscopic Shears - 5 mm Diameter / 36 cm Length
2016-09-22
FMwand - FMwand Handpiece with Integrated Smoke Evacuation - 150 mm Length with 2 mm Dissecting Blade
2016-09-22
FMsealer - FMsealer Open Shears
2016-06-15