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510(k) K912252

INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT by Fiberoptic Medical Products, Inc. — Product Code FST

K912252 is an FDA 510(k) premarket notification submitted by Fiberoptic Medical Products, Inc. for the device "INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT". The FDA issued a decision of Substantially Equivalent on June 27, 1991. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Fiberoptic Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1991
Date Received
May 21, 1991
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 Fiberoptic Medical Products, Inc.

  • K944686 — FIBEROPTIC LARYNGOSCOPE HANDLE (November 4, 1994)
  • K933598 — ENDOSTAR(TM) STYLET (January 25, 1994)
  • K921393 — IMAGICA MICRO-ENDOSCOPE (August 20, 1992)
  • K883779 — WALLABY(TM) BLANKET (November 14, 1988)

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