Cleared Traditional

K183461 - Rusch Flocath Hydrophilic Intermittent ...

K183461 is an FDA 510(k) clearance for Rusch Flocath Hydrophilic Intermittent ..., manufactured by Teleflexmedical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K183461 · Teleflexmedical, Inc. · Gastroenterology & Urology device
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May 2019
Decision
145d
Days
Class 2
Risk

K183461 is an FDA 510(k) clearance for the Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Interm.... Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on May 8, 2019 after a review of 145 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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K183461

510(k) Number K183461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 14, 2018
Decision Date May 08, 2019
Days to Decision 145 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
15d slower than avg
Panel avg: 130d · This submission: 145d
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 45
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K183461.
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K180801 · B.Braun Medical, Inc. · Nov 2018