Cleared Traditional

RocaTub Ureteral Catheter (K192183) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192183 · Promepal Sam · Gastroenterology & Urology device
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Apr 2020
Decision
255d
Days
Class 2
Risk

K192183 is an FDA 510(k) clearance for the RocaTub Ureteral Catheter. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Promepal Sam (Monaco, MC). The FDA issued a Cleared decision on April 23, 2020 after a review of 255 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 Promepal Sam devices

Submission Details

510(k) Number K192183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2019
Decision Date April 23, 2020
Days to Decision 255 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
125d slower than avg
Panel avg: 130d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EYB Catheter, Ureteral, Gastro-urology
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 - EYB Catheter, Ureteral, Gastro-urology

All 27
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K192183.
Dornier MINNOW Ureteral Catheter
K191187 · Dornier Medtech America, Inc. · Sep 2019
UPJ Occlusion Balloon Catheter
K183323 · Cook Incorporated · Aug 2019
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
K182695 · Cook Incorporated · Jun 2019
Ureteric Catheters
K182122 · Coloplast Corp. · Oct 2018
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
K180182 · Cook Incorporated · Sep 2018
BARD DUAL LUMEN URETERAL CATHETER
K032521 · C.R. Bard, Inc. · Nov 2003