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510(k) K071180

SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 by Engineered Medical Solutions Co., LLC — Product Code FTD

K071180 is an FDA 510(k) premarket notification submitted by Engineered Medical Solutions Co., LLC for the device "SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001". The FDA issued a decision of Substantially Equivalent on June 20, 2007. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Engineered Medical Solutions Co., LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2007
Date Received
April 30, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Lamp, Surgical
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Engineered Medical Solutions Co., LLC

  • K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL (December 5, 2013)

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)
  • 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