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510(k) K924897

XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 by Medical Devices, Inc. — Product Code GCT

K924897 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300". The FDA issued a decision of Substantially Equivalent on July 6, 1993. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1993
Date Received
September 29, 1992
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 Medical Devices, Inc.

  • K002280 — PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 (February 5, 2001)
  • K930084 — MICRO-ARTHROSCOPE (September 1, 1995)
  • K943126 — ELECTROFLEX (December 5, 1994)
  • K940012 — SMARTBRACE ELECTRODE (December 5, 1994)
  • K935132 — HOME MICROCURRENT HMC (March 14, 1994)
  • K934619 — FLEXMATE (February 23, 1994)
  • K930053 — VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 (May 17, 1993)
  • K923914 — IF-II (TM), MODEL 7200 (November 6, 1992)
  • K920071 — MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 (July 21, 1992)
  • K915694 — MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR (June 18, 1992)

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