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510(k) K951971

XENON LIGHT SOURCE by Envision Medical Corp. — Product Code GCT

K951971 is an FDA 510(k) premarket notification submitted by Envision Medical Corp. for the device "XENON LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on May 24, 1995. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Envision Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1995
Date Received
April 27, 1995
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 Envision Medical Corp.

  • K970605 — 3-CCD DIGITAL CAMERA (May 22, 1997)
  • K953438 — SURGICAL INTEGRATED CAMERA SYSTEM (November 6, 1995)
  • K944707 — ISOLATED CAMERA HEAD (October 7, 1994)
  • K934092 — CAMERA, SURGICAL AND ACCESSORIES (January 7, 1994)

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