Home / 510(k) Clearances / K003423

510(k) K003423

ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 by St. Francis Medical Equipment Co., Ltd. — Product Code FTD

K003423 is an FDA 510(k) premarket notification submitted by St. Francis Medical Equipment Co., Ltd. for the device "ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055". The FDA issued a decision of Substantially Equivalent on February 22, 2001. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2001
Date Received
November 3, 2000
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 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