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510(k) K951895

ACCU-BEAM 300W XENON LIGHT SOURCE by Tti Medical — Product Code GCT

K951895 is an FDA 510(k) premarket notification submitted by Tti Medical for the device "ACCU-BEAM 300W 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. Tti Medical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1995
Date Received
April 24, 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 Tti Medical

  • K952006 — ACCU-BEAM FIBER OPTIC HANDPIECE (May 31, 1995)
  • K945648 — ACCU-BEAM C02 LASER HANDPIECE (February 24, 1995)
  • K921208 — ACCU-BEAM TUBE SET (June 1, 1993)
  • K910978 — ACCU-BEAM LAPAROSCOPIC SYSTEM (November 7, 1991)
  • K895656 — ACCU-BEAM WAVEGUIDE (February 22, 1990)
  • K890922 — ACCU-BEAM YAG FIBER (May 15, 1989)
  • K870063 — CO2 LASER BRONCHOSCOPE SET (March 9, 1987)
  • K870046 — DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET (March 5, 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