Home / 510(k) Clearances / K141330

510(k) K141330

ENDO-CORD by Enroxtech, Inc. — Product Code FST

K141330 is an FDA 510(k) premarket notification submitted by Enroxtech, Inc. for the device "ENDO-CORD". The FDA issued a decision of Substantially Equivalent on December 15, 2014. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2014
Date Received
May 21, 2014
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 for product code FST

  • K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cab (June 30, 2020)
  • 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)
  • K090070 — INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (April 22, 2009)

FDA data resources