Home / 510(k) Clearances / K090070

510(k) K090070

INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM by Invuity, Inc. — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2009
Date Received
January 12, 2009
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 Invuity, Inc.

  • K191583 — PhotonBlade with Smoke Evacuation (March 6, 2020)
  • K162053 — PhotonBlade (September 15, 2016)
  • K113697 — EIGR SURGICAL ILLUMINATION SYSTEM (February 10, 2012)

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)