510(k) K031068 ยท FSY Light, Surgical, Ceiling Mounted
STRYKER VISUM SURGICAL LIGHTING SYSTEM
| Applicant | Stryker Endoscopy, San Jose CA, US |
| Decision | Substantially Equivalent, Aug 12, 2003 |
| Received | Apr 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2012 | Stryker Communications Corp Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light. Terminated |
FSY | None listed |
| Oct 28, 2011 | Stryker Communications Corp Visum LED Surgical Lights/ Visum Halogen Surgical Lights.
Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208
Visum LED Surgical Lights and Visum Halogen Surgical Lights ar Terminated |
FSY | 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.