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510(k) K123776

POLARIS 100/200 by Drager Medical GmbH — Product Code FTD

K123776 is an FDA 510(k) premarket notification submitted by Drager Medical GmbH for the device "POLARIS 100/200". The FDA issued a decision of Substantially Equivalent on March 8, 2013. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Drager Medical GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2013
Date Received
December 10, 2012
Clearance Type
Abbreviated
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 Drager Medical GmbH

  • K062267 — OXYLOG 3000 (October 31, 2006)

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)
  • 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)
  • K010724 — SOLA 700,SOLA 500, SOLA 300 (June 7, 2001)

FDA data resources