510(k) K111475 ยท GEX Powered Laser Surgical Instrument
AURIGA XL
| Applicant | Starmedtec GmbH, Starnberg, DE |
| Decision | Substantially Equivalent, Sep 28, 2011 |
| Received | May 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2019 | Boston Scientific Corporation AURIGA XL 4007 BRAZIL SYSTEM
Model: M0068FS4007B0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in s Terminated |
GEX | None listed |
| May 22, 2019 | Boston Scientific Corporation AURIGA XL 4007 GENERAL SYSTEM
UPN: M0068FS4007G0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in sur Terminated |
GEX | None listed |
| May 22, 2019 | Boston Scientific Corporation AURIGA XL 4007 GENERAL - DEMO SYSTEM
UPN: M0068FS4007GD0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be use Terminated |
GEX | None listed |
| May 22, 2019 | Boston Scientific Corporation AURIGA XL 4007 GENERAL - ZERO
COST SYSTE
UPN: FS4007GZ0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used Terminated |
GEX | None listed |
| May 22, 2019 | Boston Scientific Corporation AURIGA 30 BRAZIL SYSTEM
UPN: M0068S30B0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical pro Terminated |
GEX | None listed |
| May 22, 2019 | Boston Scientific Corporation AURIGA 30 BRAZIL ZERO COST SYSTEM
UPN: M0068S30BZ0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in s Terminated |
GEX | None listed |
| May 22, 2019 | Boston Scientific Corporation AURIGA 30 GENERAL SYSTEM
UPN: M0068S30G0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical pr Terminated |
GEX | None listed |
| May 22, 2019 | Boston Scientific Corporation AURIGA 30 GENERAL - DEMO SYSTEM
UPN: M0068S30GD0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in su Terminated |
GEX | None listed |
| May 22, 2019 | Boston Scientific Corporation AURIGA 30 GENERAL ZERO COST SYSTEM
UPN: M0068S30GZ0
Product Usage:
The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in Terminated |
GEX | None listed |
| Mar 5, 2018 | Boston Scientific Corporation Auriga 30 Laser System, Universal Part Number: M0068S30G0.
Intended to be used in surgical procedures. Terminated |
GEX | None listed |
| Mar 5, 2018 | Boston Scientific Corporation Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0.
Intended to be used in surgical procedures. Terminated |
GEX | None listed |
| Oct 8, 2014 | Boston Scientific Corporation StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453 Terminated |
GEX | None listed |
| Oct 8, 2014 | Boston Scientific Corporation StarMedTec LightTrail Reusable Fibers, 600 um; Material/Part Number: 6455 Terminated |
GEX | None listed |
| Oct 8, 2014 | Boston Scientific Corporation StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.