Cleared Special

VAPRO PLUS INTERMITTENT CATHETER (K110862) - FDA 510(k) Clearance

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

K110862 · Hollister Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
28d
Days
Class 2
Risk

K110862 is an FDA 510(k) clearance for the VAPRO PLUS 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 April 26, 2011 after a review of 28 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 K110862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2011
Decision Date April 26, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
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 28
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K110862.
SpeediCath Flex Coude Pro
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K172278 · Cook Incorporated · Nov 2017
Actreen Mini Intermittent Urinary Catheters
K151772 · B.Braun Medical, Inc. · Feb 2016
DILATION CATHETER, BALLOON
K965067 · Boston Scientific Corp · Jan 1997
CATHETER, SILICONE FOLEY (BARDEX)
K760093 · C.R. Bard, Inc. · Aug 1976
TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG
K760253 · C.R. Bard, Inc. · Aug 1976