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510(k) K130513

VOLISTA 400; VOLISTA 600 by Maquet S.A.S. — Product Code FTD

K130513 is an FDA 510(k) premarket notification submitted by Maquet S.A.S. for the device "VOLISTA 400; VOLISTA 600". The FDA issued a decision of Substantially Equivalent on May 8, 2013. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Maquet S.A.S. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2013
Date Received
February 27, 2013
Clearance Type
Special
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 Maquet S.A.S.

  • K214120 — GSS610N21 Series Steam Sterilizer (May 18, 2022)
  • K201927 — Getinge GSS610N Series Steam Sterilizer (March 1, 2021)
  • K172159 — Getinge GSS67N Series Steam Sterilizer (January 30, 2018)
  • K113679 — LUCEA LED SURGICAL LIGHT SYSTEM (January 12, 2012)
  • K070442 — POWERLED SURGICAL LIGHT SYSTEM (March 16, 2007)
  • K030071 — SERVO GUARD, MODEL 64 81 290 EH88E (April 26, 2004)

Other clearances for product code FTD

  • K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL (December 5, 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)
  • K010724 — SOLA 700,SOLA 500, SOLA 300 (June 7, 2001)

FDA data resources