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510(k) K040949

VIADUCT MINISCOPE AND ACCESSORIES by Acueity, Inc. — Product Code GCT

K040949 is an FDA 510(k) premarket notification submitted by Acueity, Inc. for the device "VIADUCT MINISCOPE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on May 7, 2004. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Acueity, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2004
Date Received
April 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Acueity, Inc.

  • K032847 — EXCISOR BIOPTOME, MODEL 01-0004 (September 26, 2003)
  • K032430 — ACUEITY MEDICAL LIGHT SOURCE (September 5, 2003)
  • K011189 — VIADUCT MICROENDOSCOPE AND ACCESSORIES (July 16, 2001)

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)
  • 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)
  • K992050 — LUMENON XENON LIGHT SOURCE (September 14, 1999)

FDA data resources