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510(k) K012265

METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 by Circon Video — Product Code FCW

K012265 is an FDA 510(k) premarket notification submitted by Circon Video for the device "METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088". The FDA issued a decision of Substantially Equivalent on October 17, 2001. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500. Circon Video has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2001
Date Received
July 19, 2001
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 by Circon Video

  • K012758 — URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE (April 9, 2002)
  • K011876 — DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 (January 8, 2002)
  • K011849 — MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETER (December 10, 2001)
  • K012929 — FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 (November 19, 2001)
  • K012951 — APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE (November 9, 2001)
  • K012925 — DUR-8, MODELS DUR-8 (November 7, 2001)
  • K012153 — LOWSLEY SUPRAPUBIC TRACTOR (September 19, 2001)
  • K011848 — CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE (September 11, 2001)
  • K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (October 24, 1997)
  • K914883 — CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG (January 15, 1993)

Other clearances for product code FCW

  • K131226 — NOVAPROBE LED LIGHT SOURCE (July 24, 2014)
  • K123956 — POWER LED 175 (January 25, 2013)
  • K123359 — OVS1 VIDEO SYSTEM (December 19, 2012)
  • 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)
  • K000229 — VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE (March 21, 2000)

FDA data resources