invuity.comPhotonBlade With Smoke Evacuation
Invuity Inc.
INVUITY, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011394215 | 3007037347 | INVUITY, INC. | 1 | N | 2020-04-25 | 444 de Haro St San Francisco CA US 94107 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816728020165 | Synthes Fiber Optic Cable - Intended to provide surgical site illumination from a high intensity light source. | 8667117768 | customerservice@invuity.com |
| 00816728020172 | Synthes Fiber Optic Cable - Intended to provide surgical site illumination from a high intensity light source. | 8667117768 | customerservice@invuity.com |
| 00816728020189 | Invuity® Fiber Optic Cable - The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to provide surgical site illumination from a high intensity light source. | 8667117768 | customerservice@invuity.com |
| 00816728020219 | Invuity® Fiber Optic Cable - The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to provide surgical site illumination from a high intensity light source. | 8667117768 | customerservice@invuity.com |
| 00816728020233 | Eikon Sterilization Tray - The Eikon Sterilization Tray is intended to allow sterilization of the enclosed medical devices. | 8667117768 | customerservice@invuity.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 224596 | 1316128428 | K191583 | PhotonBlade with Smoke Evacuation | GEI | 2020-03-06 |
| 224596 | 1940351877 | K162053 | PhotonBlade | GEI | 2016-09-15 |
| 224596 | 1214029842 | K132475 | FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM | OWN | 2014-05-07 |
| 224596 | 2000900758 | K113697 | EIGR SURGICAL ILLUMINATION SYSTEM | FST | 2012-02-10 |
| 224596 | 1965760643 | K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | FST | 2009-04-22 |
| 224596 | 1660970403 | K000904 | PENADAPT 10 | FYD | 2000-06-08 |
| 224596 | 1306061146 | ||||
| 224596 | 1335692036 | ||||
| 224596 | 1337622558 | ||||
| 224596 | 1459595140 | ||||
| 224596 | 1857934355 | ||||
| 224596 | 1860049516 | ||||
| 224596 | 1921302824 |
Product Codes Associated With Registrations#
PMN#
PhotonBlade
Invuity Inc.
EIGR SURGICAL ILLUMINATION SYSTEM
INVUITY, INC.
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
INVUITY, INC.
GUDID#
Synthes Fiber Optic Cable - Intended to provide surgical site illumination from a high intensity light source.
2016-09-22
Synthes Fiber Optic Cable - Intended to provide surgical site illumination from a high intensity light source.
2016-09-22
Invuity® Fiber Optic Cable - The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to provide surgical site illumination from a high intensity light source.
2016-09-22
Invuity® Fiber Optic Cable - The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to provide surgical site illumination from a high intensity light source.
2016-09-22
Eikon Sterilization Tray - The Eikon Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
2016-09-22
Invuity® Sterilization Tray - The Invuity® Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
2016-09-22
Invuity® Fiber Optic Sterilization Tray - The Invuity® Fiber Optic Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
2016-09-22
Invuity® Steam Sterilization Tray - The Invuity Steam Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
2016-09-22
Invuity® Steam Sterilization Tray - The Invuity Steam Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
2016-09-22
Breiten Sterilization Tray - The Breiten Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
2016-09-22
Breiten Sterilization Tray - The Breiten Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
2016-09-22
PhotonSaber Y - The Invuity PhotonSaber Y with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
2016-09-22
PhotonBlade™ - he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
2019-06-03
PhotonGuide - The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
2019-06-03
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-08-09
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-08-09
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-10-07
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-10-07
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-08-09
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-08-09
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-10-07
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-10-07
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-08-09
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-08-09
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-10-07
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-10-07
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-08-09
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-10-07
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-10-07
Eikon LT Adapt Smoke Evacuation - Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
2019-08-09
PhotonGuide Adapt - The PhotonGuide Adapt is intended to provide surgical site illumination from a high intensity light source.
2019-06-03
PhotonBlade™ - he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
2019-06-03
Eigr™ Saber Waveguide - The Invuity Eigr Saber Waveguide with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
2016-07-12
Eigr™ Saber Waveguide - The Invuity Eigr Saber Waveguide with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
2016-07-12
Eigr™ Saber Waveguide - The Invuity Eigr Saber Waveguide with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
2016-07-12
Eigr™ Saber Waveguide - The Invuity Eigr Saber Waveguide with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
2016-07-12
Eigr™ Saber Waveguide - Intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
2016-07-12
Eigr™ Waveguide - The Eigr Waveguide, Narrow/Flat, LC is intended to provide surgical site illumination from a high intensity light source.
2016-09-22
PhotonGuide - The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
2016-09-22
PhotonGuide - The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
2016-09-22