510(k) K033132 ยท GCJ Laparoscope, General & Plastic Surgery
STRYKER SWITCHPOINT INFINITY
| Applicant | Stryker Communications Corp., Poway CA, US |
| Decision | Substantially Equivalent, Sep 2, 2004 |
| Received | Sep 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2011 | Stryker Communications Corp Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208
Stryker EDS (Equipment Delivery System) Booms and Flat Panel Suspensions are intended for use as ceiling-mounted devices t Terminated |
GCJ | None listed |
| Jun 15, 2010 | Stryker Communications Corp The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, video, data router and teleconferencing interface for the operating room.
The SwitchPoint Infinity 2 (SPI2) and S Terminated |
GCJ | None listed |
| May 21, 2010 | Stryker Communications Corp Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251.
Intended to illuminate the operative site during surgical procedures with high intensity l Terminated |
FSY | None listed |
| May 21, 2010 | Stryker Communications Corp Stryker Equipment Delivery System (EDS); Ceiling Mounted Equipment Booms; Catalog Number: 0682000383, 0682000384, 0682000385(A-D), 0682000386(A-D), 0682000426, 0682000429(A-D), 0682000326, 0682000311 Terminated |
FSY | None listed |
| May 21, 2010 | Stryker Communications Corp Stryker VISUM Halogen Surgical Lights (Ceiling Mounted Surgical Lights), Catalog Number: 0682000106; 0682000107.
Intended to illuminate the operative site during surgical procedures with high intens Terminated |
FSY | None listed |
| May 21, 2010 | Stryker Communications Corp SwitchPoint Element (SPE) Control System. Control System for audio/video, surgical, and room equipment. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, 067000233.
Used for direct contr Terminated |
GCJ | None listed |
| May 21, 2010 | Stryker Communications Corp SwitchPoint Infinity (SPI) Control System. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, & 067000233.
Used for direct control of room equipment, audio/video equipment, and indirect co Terminated |
GCJ | None listed |
| May 21, 2010 | Stryker Communications Corp Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers: 0682000863, 06820001009, 0682001010, 0682001076, 0682000864, 0682000857, 0682000858, 0682001077, 0682000865, 06820010 Terminated |
BRY | None listed |
| Sep 29, 2008 | Stryker Communications Corp OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component of the Switchpoint Infinity 1, Switchpoint Infinity 2, and Switchpoint Element. The OPHIT Optical Digital V Terminated |
GCJ | None listed |
| Jan 12, 2008 | Stryker Communications Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These Terminated |
GCJ | None listed |
| Jan 12, 2008 | Stryker Communications Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used wit Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.