Cleared Traditional

K090960 - VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,

K090960 is an FDA 510(k) clearance for VAPRO INTERMITTENT CATHETER, manufactured by Hollister, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K090960 · Hollister, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
136d
Days
Class 2
Risk

K090960 is an FDA 510(k) clearance for the VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 7.... Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on August 20, 2009 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K090960

510(k) Number K090960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date August 20, 2009
Days to Decision 136 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
5d slower than avg
Panel avg: 131d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 63
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K090960.
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
K111405 · Hangzhou Bever Medical Devices Co., Ltd. · Feb 2012
VAPRO PLUS INTERMITTENT CATHETER
K110862 · Hollister Incorporated · Apr 2011
HAKKI URINARY CATHETER
K101900 · Hakki Medical Technologies, Inc. · Feb 2011
SPEEDICATH COMPACT
K072808 · Coloplast Corp. · Nov 2007
GUARDIANCATHETER-URINARY DRAINAGE CATHETER
K063795 · Marian Medical, Inc. · Mar 2007
PEDIATRIC URINARY CATHETER
K060268 · Clay Kennard · Feb 2006