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510(k) K963227

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 by Products For Medicine — Product Code GCT

K963227 is an FDA 510(k) premarket notification submitted by Products For Medicine for the device "WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175". The FDA issued a decision of Substantially Equivalent on October 23, 1996. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Products For Medicine has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1996
Date Received
August 19, 1996
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 Products For Medicine

  • K955510 — X6000D SILENT SUN LIGHT SOURCE (January 31, 1996)
  • K953089 — I-SPOUSE (October 16, 1995)
  • K951704 — NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION (June 28, 1995)
  • K951703 — TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS (June 28, 1995)
  • K883658 — I-SPOSE EYE SHIELD (October 25, 1988)

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