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510(k) K853948

MINNESOTA SCIENTIFIC, INC. OMNI-BEAM by Minnesota Scientific, Inc. — Product Code HBI

K853948 is an FDA 510(k) premarket notification submitted by Minnesota Scientific, Inc. for the device "MINNESOTA SCIENTIFIC, INC. OMNI-BEAM". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Minnesota Scientific, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
September 24, 1985
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 Minnesota Scientific, Inc.

  • K872919 — OMNI-TRACT CORRAL RETRACTOR (August 11, 1987)
  • K853947 — OMNI-TRACT CHEST WALL & LUNA RETRACTOR (October 16, 1985)
  • K842762 — OMNI-TRACT SURGICAL RETRACTOR SYS (August 17, 1984)
  • K810282 — OPERATING TABLE ACCESSORY CLAMP (February 26, 1981)

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