Cleared Special

K180070 - SpeediCath Flex Coude Pro

K180070 is an FDA 510(k) clearance for SpeediCath Flex Coude Pro, manufactured by Coloplast. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Special 510(k) pathway after a 24-day FDA review.

K180070 · Coloplast · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Feb 2018
Decision
24d
Days
Class 2
Risk

K180070 is an FDA 510(k) clearance for the SpeediCath Flex Coude Pro. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on February 2, 2018 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Coloplast devices

FDA 510(k) Submission Details - K180070

510(k) Number K180070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2018
Decision Date February 02, 2018
Days to Decision 24 days
Submission Type Special
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
106d faster than avg
Panel avg: 130d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - GBM Catheter, Urethral

All 46
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K180070.
SpeediCath Standard
K180258 · Coloplast · Oct 2018
GentleCath Glide Intermittent Urinary Catheter
K181206 · Convatec Limited · Aug 2018
VaPro 2 Intermittent Catheter
K180824 · Hollister Incorporated · Jun 2018
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · Cook Incorporated · Nov 2017
SpeediCath Flex Coude
K161672 · Coloplast Corp. · Sep 2016
Actreen Mini Intermittent Urinary Catheters
K151772 · B.Braun Medical, Inc. · Feb 2016