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510(k) K883201

VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS by Vital Metrics, Inc. — Product Code HBI

K883201 is an FDA 510(k) premarket notification submitted by Vital Metrics, Inc. for the device "VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS". The FDA issued a decision of Substantially Equivalent on September 26, 1988. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Vital Metrics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1988
Date Received
July 28, 1988
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 Vital Metrics, Inc.

  • K882956 — VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION (August 3, 1988)
  • K844973 — IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES (March 18, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K840917 — URINARY MONITORING SYS 240 (May 1, 1984)
  • K834448 — URINARY DRAINAGE CONTAINER (February 10, 1984)
  • K832526 — UROTRACK PLUS (September 19, 1983)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)

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