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510(k) K111342

LIGHT GUIDE CABLE by Schott North America — Product Code HBI

K111342 is an FDA 510(k) premarket notification submitted by Schott North America for the device "LIGHT GUIDE CABLE". The FDA issued a decision of Substantially Equivalent on November 25, 2011. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2011
Date Received
May 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code HBI

  • K223183 — Light-Guide Cables (January 13, 2023)
  • K163185 — OptiLux LED Illuminator (November 21, 2016)
  • K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES (April 9, 2015)
  • K052979 — 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (October 31, 2005)
  • K021931 — ENDOSCOPIC FIBEROPTIC CABLE (September 6, 2002)
  • K991208 — ENDOSCOPIC FIBEROPTIC CABLE (June 23, 1999)
  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)
  • K922462 — NEXTEC FIBEROPTIC CABLES (September 21, 1992)

FDA data resources