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510(k) K012153

LOWSLEY SUPRAPUBIC TRACTOR by Circon Video — Product Code KOB

K012153 is an FDA 510(k) premarket notification submitted by Circon Video for the device "LOWSLEY SUPRAPUBIC TRACTOR". The FDA issued a decision of Substantially Equivalent on September 19, 2001. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Circon Video has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2001
Date Received
July 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Suprapubic (And Accessories)
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by Circon Video

  • K012758 — URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE (April 9, 2002)
  • K011876 — DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 (January 8, 2002)
  • K011849 — MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETER (December 10, 2001)
  • K012929 — FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 (November 19, 2001)
  • K012951 — APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE (November 9, 2001)
  • K012925 — DUR-8, MODELS DUR-8 (November 7, 2001)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)
  • K011848 — CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE (September 11, 2001)
  • K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (October 24, 1997)
  • K914883 — CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG (January 15, 1993)

Other clearances for product code KOB

  • K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set (November 1, 2024)
  • K181097 — Cook Cystostomy Catheter Set (January 18, 2019)
  • K182709 — One-Step Suprapubic Introducer (December 26, 2018)
  • K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (October 30, 2018)
  • K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SET (January 17, 2014)
  • K120127 — SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SY (October 26, 2012)
  • K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (March 4, 2002)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)
  • K945480 — MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (August 28, 1995)

FDA data resources