Cleared Traditional

K182709 - One-Step Suprapubic Introducer

K182709 is the FDA 510(k) clearance for One-Step Suprapubic Introducer by Cook Incorporated. It is a Class 2 Gastroenterology & Urology device (product code KOB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K182709 · Cook Incorporated · Gastroenterology & Urology device
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Dec 2018
Decision
90d
Days
Class 2
Risk

K182709 is an FDA 510(k) clearance for the One-Step Suprapubic Introducer. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 26, 2018 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Incorporated devices

Submission Details

510(k) Number K182709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date December 26, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOB Catheter, Suprapubic (and Accessories)

All 11
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K182709.
AMT Low-Profile Suprapubic Catheter & Drainage Set
K240514 · Applied Medical Technology, Inc. · Nov 2024
Cook Cystostomy Catheter Set
K181097 · Cook Incorporated · Jan 2019
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
K182066 · Cook Incorporated · Oct 2018
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969 · The Kendal Co. · Apr 1997
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · Cook Urological, Inc. · Aug 1995
SUPRAPUBIC FLOW CONTROLLER
K904798 · Olympus Corp. · Nov 1991