Cleared Traditional

K241734 - Wellead Hydrophilic Intermittent Cathet...

Also marketed or referenced as:
Wellead® Hydrophilic Intermittent Catheter Compact

K241734 is an FDA 510(k) clearance for Wellead Hydrophilic Intermittent Cathet..., manufactured by Well Lead Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K241734 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
261d
Days
Class 2
Risk

K241734 is an FDA 510(k) clearance for the Wellead® Hydrophilic Intermittent Catheter Ready to Use. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 5, 2025 after a review of 261 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 Well Lead Medical Co., Ltd. devices

FDA 510(k) Submission Details - K241734

510(k) Number K241734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2024
Decision Date March 05, 2025
Days to Decision 261 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
131d slower than avg
Panel avg: 130d · This submission: 261d
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 46
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K241734.
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
K213283 · Convatec Limited · Jun 2022
Intermittent Catheter (Not Finalized)
K211436 · Hollister Incorporated · Jan 2022
SpeediCath Compact Set
K200820 · Coloplast · Nov 2020
SpeediCath Compact Set
K192904 · Coloplast · Nov 2020
SpeediCath Soft
K200142 · Coloplast · Jul 2020
Jimushi Sterile Urethral Catheter for single use
K200134 · Hangzhou Jimushi Meditech Co., Ltd. · Jun 2020