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510(k) K141781

KOGENT SPETZLER LIGHTED SUCTION TUBES by Katalyst Surgical, LLC — Product Code HBI

K141781 is an FDA 510(k) premarket notification submitted by Katalyst Surgical, LLC for the device "KOGENT SPETZLER LIGHTED SUCTION TUBES". The FDA issued a decision of Substantially Equivalent on April 9, 2015. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Katalyst Surgical, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2015
Date Received
July 2, 2014
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 Katalyst Surgical, LLC

  • K213610 — Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, K (October 7, 2022)
  • K192963 — Kogent Torus Ultrasonic Aspirator (June 19, 2020)
  • K163632 — Katalyst Cyclophotocoagulation Probe (June 15, 2017)
  • K140362 — KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATA (September 15, 2014)
  • K123172 — KOGENT BIPOLAR FORCEPS (December 21, 2012)
  • K121187 — KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES (September 17, 2012)

Other clearances for product code HBI

  • K223183 — Light-Guide Cables (January 13, 2023)
  • K163185 — OptiLux LED Illuminator (November 21, 2016)
  • 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)
  • K922462 — NEXTEC FIBEROPTIC CABLES (September 21, 1992)

FDA data resources