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510(k) K823360

SURGICAL LIGHT by Amsco Co. — Product Code FTD

K823360 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "SURGICAL LIGHT". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Amsco Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
November 5, 1982
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 Amsco Co.

  • K912471 — EAGLE 3000 SDS (June 26, 1992)
  • K854922 — AMSCO POLARIS SL (January 24, 1986)
  • K833187 — HALL OSTEON (October 31, 1983)
  • K832945 — EAGLE 2000 STERILIZER SERIES GAS/AERA (October 19, 1983)
  • K832186 — HALL DRILL/REAMER (August 12, 1983)
  • K832188 — HALL RECIPROCATOR (August 12, 1983)
  • K832187 — HALL OSCILLATOR (August 12, 1983)
  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K811242 — DISPOSABLE STERILIZATION WRAP (May 21, 1981)

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