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510(k) K922837

S1500 XENON LIGHT SOURCE by Endomedix — Product Code HBI

K922837 is an FDA 510(k) premarket notification submitted by Endomedix for the device "S1500 XENON LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on November 3, 1992. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Endomedix has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1992
Date Received
June 12, 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 Endomedix

  • K934170 — ENDOMEDIX Y-ADAPTER (January 11, 1994)
  • K934623 — ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA (December 2, 1993)
  • K930499 — GRASPING FORCEPS FLEXIBLE STONE DISLODGER (August 16, 1993)
  • K930349 — STONE RETRIEVAL BASKET (June 9, 1993)
  • K926004 — ENDOSCOPE AND ACCOSSORIES (February 10, 1993)
  • K922082 — LAPAROSCOPIC INTRODUCER (August 3, 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)
  • K922462 — NEXTEC FIBEROPTIC CABLES (September 21, 1992)

FDA data resources