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510(k) K021931

ENDOSCOPIC FIBEROPTIC CABLE by Gulf Medical Fiberoptics — Product Code HBI

K021931 is an FDA 510(k) premarket notification submitted by Gulf Medical Fiberoptics for the device "ENDOSCOPIC FIBEROPTIC CABLE". The FDA issued a decision of Substantially Equivalent on September 6, 2002. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Gulf Medical Fiberoptics has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2002
Date Received
June 12, 2002
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 Gulf Medical Fiberoptics

  • K061690 — SURGICAL HEADLIGHT (September 15, 2006)

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)
  • 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