Cleared Traditional

K142194 - CytoSure Urinary Access System

K142194 is an FDA 510(k) clearance for CytoSure Urinary Access System, manufactured by Emmy Medical. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K142194 · Emmy Medical · Gastroenterology & Urology device
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Dec 2014
Decision
130d
Days
Class 2
Risk

K142194 is an FDA 510(k) clearance for the CytoSure Urinary Access System. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Emmy Medical (Holliston, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Emmy Medical devices

FDA 510(k) Submission Details - K142194

510(k) Number K142194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2014
Decision Date December 19, 2014
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAJ Device Classification - Class 2, Special Controls

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 63
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K142194.
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