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510(k) K895715

HANAULUX(R) 2000 by W.C. Heraeus GmbH — Product Code FTD

K895715 is an FDA 510(k) premarket notification submitted by W.C. Heraeus GmbH for the device "HANAULUX(R) 2000". The FDA issued a decision of Substantially Equivalent on October 13, 1989. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. W.C. Heraeus GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1989
Date Received
September 25, 1989
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 W.C. Heraeus GmbH

  • K875078 — HERACURE LS 500 (February 22, 1988)

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