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510(k) K182709

One-Step Suprapubic Introducer by Cook Incorporated — Product Code KOB

K182709 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "One-Step Suprapubic Introducer". The FDA issued a decision of Substantially Equivalent on December 26, 2018. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Cook Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2018
Date Received
September 27, 2018
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 Cook Incorporated

  • K233177 — Nest VT Vitrification Device (March 8, 2024)
  • K222254 — Gunther Tulip Vena Cava Filter Retrieval Set (May 16, 2023)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)
  • K203670 — Extra Large Check-Flo Introducer (February 16, 2021)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K191163 — Lumax Guiding Catheter (December 12, 2019)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K190084 — McLean-Ring Enteral Feeding Tube Set (October 11, 2019)

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)
  • 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)
  • K012153 — LOWSLEY SUPRAPUBIC TRACTOR (September 19, 2001)
  • 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