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510(k) K905282

ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE by Frantz Medical Development, Ltd. — Product Code GCT

K905282 is an FDA 510(k) premarket notification submitted by Frantz Medical Development, Ltd. for the device "ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 19, 1991. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Frantz Medical Development, Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 19, 1991
Date Received
November 23, 1990
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 Frantz Medical Development, Ltd.

  • K981541 — CLEARSTAR ENTERAL NUTRITION PUMP (August 13, 1998)
  • K873119 — FLEXIFLO COMPANION ENTERAL NUTRITION PUMP (November 5, 1987)
  • K871710 — BIOPSY FORCEPS (August 10, 1987)
  • K863508 — FRANTZ MEDICAL ELECTRODE (February 6, 1987)

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