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510(k) K123359

OVS1 VIDEO SYSTEM by Olive Medical Corp. — Product Code FCW

K123359 is an FDA 510(k) premarket notification submitted by Olive Medical Corp. for the device "OVS1 VIDEO SYSTEM". The FDA issued a decision of Substantially Equivalent on December 19, 2012. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2012
Date Received
October 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances for product code FCW

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  • K123956 — POWER LED 175 (January 25, 2013)
  • K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (September 20, 2012)
  • K093792 — LED LIGHT SOURCE (March 18, 2010)
  • K091968 — KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C (September 14, 2009)
  • K082813 — STRYKER LED LIGHTSOURCE (December 19, 2008)
  • K081477 — LUXTEC MLX LIGHT SOURCE (June 18, 2008)
  • K032430 — ACUEITY MEDICAL LIGHT SOURCE (September 5, 2003)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)
  • K000229 — VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE (March 21, 2000)

FDA data resources