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510(k) K021717

ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 by World of Medicine Lemke GmbH — Product Code GCT

K021717 is an FDA 510(k) premarket notification submitted by World of Medicine Lemke GmbH for the device "ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5". The FDA issued a decision of Substantially Equivalent on August 20, 2002. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. World of Medicine Lemke GmbH has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2002
Date Received
May 23, 2002
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 World of Medicine Lemke GmbH

  • K024251 — SIGHTFIX (March 18, 2003)
  • K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3 (January 14, 2003)
  • K021456 — ER150/M2 (August 1, 2002)
  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (June 5, 2002)
  • K014158 — ENDOSCOPIC CAMERA TC804/C4 (March 14, 2002)
  • K020336 — ENDOSCOPIC CAMERA MC404/C3 (March 14, 2002)

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)
  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (June 5, 2002)
  • K013880 — DAYLITE XENON LIGHT SOURCES (December 7, 2001)
  • K992050 — LUMENON XENON LIGHT SOURCE (September 14, 1999)

FDA data resources