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510(k) K864801

THE KEYMED HI-LIGHT 250 LIGHT SOURCE by Keymed, Inc. — Product Code GCT

K864801 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "THE KEYMED HI-LIGHT 250 LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on December 24, 1986. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Keymed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1986
Date Received
December 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Keymed, Inc.

  • K100803 — OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (April 22, 2010)
  • K921179 — OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 (March 29, 1993)
  • K881004 — OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR (May 12, 1988)
  • K861821 — KEYMED FIBERSCOPE AUTO DISINFECTOR (February 12, 1987)
  • K862000 — KEYMED FLEXIBLE ESOPHAGEAL DILATORS (August 12, 1986)
  • K860528 — THE KEYMED FIBERSCOPE STERILIZATION CASE (July 15, 1986)
  • K861147 — UCS-2, ULTRASONIC CLEANING SOLUTION (June 23, 1986)
  • K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (June 17, 1986)
  • K851149 — KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (November 26, 1985)
  • K854304 — KEYMED OFFICE COUCH (November 12, 1985)

Other clearances for product code GCT

  • K093125 — ALPHAXENON LIGHT 180 W AND 300 W (January 27, 2010)
  • K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (December 18, 2008)
  • K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE (August 20, 2007)
  • K040949 — VIADUCT MINISCOPE AND ACCESSORIES (May 7, 2004)
  • K022490 — KSEA MEDI PACK (September 29, 2003)
  • K031994 — LINVATEC 300W XENON LIGHT SOURCE (August 21, 2003)
  • K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3 (January 14, 2003)
  • K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (August 20, 2002)
  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (June 5, 2002)
  • K013880 — DAYLITE XENON LIGHT SOURCES (December 7, 2001)

FDA data resources