Cleared Traditional

K111405 - BEVER UNOCATED / COATED

K111405 is the FDA 510(k) clearance for BEVER UNOCATED / COATED by Hangzhou Bever Medical Devices Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code GBM) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K111405 · Hangzhou Bever Medical Devices Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
270d
Days
Class 2
Risk

K111405 is an FDA 510(k) clearance for the BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP.... Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Hangzhou Bever Medical Devices Co., Ltd. (Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on February 13, 2012 after a review of 270 days - an extended review cycle.

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 Hangzhou Bever Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K111405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2011
Decision Date February 13, 2012
Days to Decision 270 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 130d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 42
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K111405.
Speedicath Compact Male
K143182 · Coloplast A/S · Jan 2015
SPEEDICATH COMPACT SET (12 FR)
K121457 · Coloplast Corp. · Oct 2012
SPEEDICATH COMPACT SET (12/18 FR)
K121458 · Coloplast A/S · Oct 2012
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
K090960 · Hollister, Inc. · Aug 2009
SPEEDICATH COMPACT
K072808 · Coloplast Corp. · Nov 2007
SPEEDICATH
K023254 · Coloplast Corp. · Jan 2003