Cleared Traditional

CystoSure Plus Catheter (K181346) - FDA 510(k) Clearance

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

K181346 · Emmy Medical, LLC · Gastroenterology & Urology device
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Aug 2018
Decision
77d
Days
Class 2
Risk

K181346 is an FDA 510(k) clearance for the CystoSure Plus Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Emmy Medical, LLC (Holliston, US). The FDA issued a Cleared decision on August 6, 2018 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emmy Medical, LLC devices

Submission Details

510(k) Number K181346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2018
Decision Date August 06, 2018
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
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 Consultant

R&Q Solutions., LLC
Christine Santagate

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 45
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K181346.
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