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510(k) K080962

LITE WAND II by Thompson Surgical Instruments, Inc. — Product Code FST

K080962 is an FDA 510(k) premarket notification submitted by Thompson Surgical Instruments, Inc. for the device "LITE WAND II". The FDA issued a decision of Substantially Equivalent on June 25, 2008. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Thompson Surgical Instruments, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2008
Date Received
April 4, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Thompson Surgical Instruments, Inc.

  • K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clam (May 13, 2022)
  • K151347 — MIS Spine Frame Instrument Case (October 16, 2015)

Other clearances for product code FST

  • K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cab (June 30, 2020)
  • K141330 — ENDO-CORD (December 15, 2014)
  • K122637 — LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 (November 1, 2012)
  • K113697 — EIGR SURGICAL ILLUMINATION SYSTEM (February 10, 2012)
  • K113330 — CABLECAP (January 12, 2012)
  • K102266 — ISOLED AC-POWERED LED HEADLIGHT SYSTEM (September 24, 2010)
  • K101496 — CABLECAP MODEL: WLF, STZ, ACM (September 14, 2010)
  • K100388 — 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS (June 22, 2010)
  • K100395 — HARMONY VLED SURGICAL LIGHTNING SYSTEM (March 17, 2010)
  • K093386 — CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST (January 28, 2010)

FDA data resources