Atlas FDA

STRYKER SWITCHPOINT INFINITY

FDA 510(k) clearance K033132 · decided 2004-09-02

Clearance details

K-number
K033132
Device name
STRYKER SWITCHPOINT INFINITY
Applicant
Stryker Communications Corp.
Decision
Substantially Equivalent
Date received
2003-09-30
Decision date
2004-09-02
Days to decision
338 days
Clearance type
Traditional
Product code
GCJ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Poway, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 Stryker EDS ( recall (Z-0138-2012)Stryker Communications Corp2011-10-28
The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice, vide recall (Z-1803-2010)Stryker Communications Corp2010-06-15
Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 06820 recall (Z-1640-2010)Stryker Communications Corp2010-05-21
Stryker Equipment Delivery System (EDS); Ceiling Mounted Equipment Booms; Catalog Number: recall (Z-1641-2010)Stryker Communications Corp2010-05-21
Stryker VISUM Halogen Surgical Lights (Ceiling Mounted Surgical Lights), Catalog Number: 0 recall (Z-1642-2010)Stryker Communications Corp2010-05-21
SwitchPoint Element (SPE) Control System. Control System for audio/video, surgical, and ro recall (Z-1643-2010)Stryker Communications Corp2010-05-21
SwitchPoint Infinity (SPI) Control System. Catalog Numbers: 067000220, 067000230, 06700023 recall (Z-1644-2010)Stryker Communications Corp2010-05-21
Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers: 06820008 recall (Z-1645-2010)Stryker Communications Corp2010-05-21
OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component recall (Z-2467-2008)Stryker Communications Corp2008-09-29
Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43- recall (Z-0302-2008)Stryker Communications2008-01-12
Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100- recall (Z-0303-2008)Stryker Communications2008-01-12