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510(k) K920167

NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL by Nextec Corp. — Product Code HBI

K920167 is an FDA 510(k) premarket notification submitted by Nextec Corp. for the device "NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL". The FDA issued a decision of Substantially Equivalent on March 23, 1992. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Nextec Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1992
Date Received
January 10, 1992
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 by Nextec Corp.

  • K922462 — NEXTEC FIBEROPTIC CABLES (September 21, 1992)
  • K921646 — NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON (May 13, 1992)

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)
  • K111342 — LIGHT GUIDE CABLE (November 25, 2011)
  • 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)

FDA data resources