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510(k) K942553

GENESIS by Burton Medical Products Corp. — Product Code FTD

K942553 is an FDA 510(k) premarket notification submitted by Burton Medical Products Corp. for the device "GENESIS". The FDA issued a decision of Substantially Equivalent on June 23, 1994. The device falls under product code FTD (Lamp, Surgical), 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
June 23, 1994
Date Received
May 31, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical
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)
  • K963682 — GENIE' SINGLE CEILING AND DOUBLE CEILING (November 13, 1996)
  • K961843 — GENIE (August 22, 1996)
  • K935102 — SATURN LIGHT (June 27, 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 FTD

  • K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL (December 5, 2013)
  • K130513 — VOLISTA 400; VOLISTA 600 (May 8, 2013)
  • K123776 — POLARIS 100/200 (March 8, 2013)
  • K111020 — ATRICURE DISSECTOR (June 9, 2011)
  • K100234 — HM-LAMP II (July 8, 2010)
  • K100884 — STRYKER KNIFELIGHT (June 25, 2010)
  • K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (June 20, 2007)
  • K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP (February 23, 2006)
  • K041681 — ATRICURE DISSECTOR (July 1, 2004)
  • K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (December 13, 2001)

FDA data resources