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 |
| 00816728020288 | Invuity® Steam Sterilization Tray - The Invuity Steam 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#
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
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
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
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
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® Sterilization Tray - The Invuity® Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
2016-09-22
Eikon Sterilization Tray - The Eikon 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® - The PhotonBlade Breast Kit consists of (1) PhotonBlade packaged with a (1) PhotonGuide, Wide / Angled illuminator for the convenience of the user. The 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. The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
2018-02-26
PhotonGuide XT System - The PhotonGuide XT System is intended to provide surgical site illumination from a high intensity light source.
2016-09-22
PhotonGuide XT System - The PhotonGuide XT System 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
Eigr™ Waveguide - The Eigr Waveguide, Narrow/Flat, LC is intended to provide surgical site illumination from a high intensity light source.
2016-09-22
Eigr™ Saber Waveguide - 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 - 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
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 Adapt - The PhotonGuide Adapt 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.
2019-10-07
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
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