Cleared Special

VaPro 2 Intermittent Catheter (K180824) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180824 · Hollister Incorporated · Gastroenterology & Urology device
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Jun 2018
Decision
84d
Days
Class 2
Risk

K180824 is an FDA 510(k) clearance for the VaPro 2 Intermittent Catheter. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on June 22, 2018 after a review of 84 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 Hollister Incorporated devices

Submission Details

510(k) Number K180824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2018
Decision Date June 22, 2018
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 27
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K180824.
Actreen Hi-Lite Cath, Actreen Hi-Lite Set
K180801 · B.Braun Medical, Inc. · Nov 2018
SpeediCath Standard
K180258 · Coloplast · Oct 2018
GentleCath Glide Intermittent Urinary Catheter
K181206 · Convatec Limited · Aug 2018
SpeediCath Flex Coude Pro
K180070 · Coloplast · Feb 2018
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · Cook Incorporated · Nov 2017
Actreen Mini Intermittent Urinary Catheters
K151772 · B.Braun Medical, Inc. · Feb 2016