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510(k) K963682

GENIE' SINGLE CEILING AND DOUBLE CEILING by Burton Medical Products Corp. — Product Code FSY

K963682 is an FDA 510(k) premarket notification submitted by Burton Medical Products Corp. for the device "GENIE' SINGLE CEILING AND DOUBLE CEILING". The FDA issued a decision of Substantially Equivalent on November 13, 1996. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Burton Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1996
Date Received
September 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Burton Medical Products Corp.

  • K101537 — AIM 200, MAJOR SURGICAL LIGHT (September 30, 2010)
  • K042395 — OUTPATIENT III MINOR SURGERY LIGHT (December 1, 2004)
  • K000639 — VISIONARY 2000 (May 25, 2000)
  • K961843 — GENIE (August 22, 1996)
  • K935102 — SATURN LIGHT (June 27, 1994)
  • K942553 — GENESIS (June 23, 1994)
  • K936088 — WAVE FLUORESCENT MAGNIFIER (April 26, 1994)
  • K931645 — HALUX TASKLIGHT (August 20, 1993)
  • K901706 — LIGHT, HEAD, EXAMINATION (July 19, 1990)
  • K893807 — MODEL 0183010, PEARL MEDICAL EXAM LIGHT (August 15, 1989)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)

FDA data resources