Cleared Special

K190987 - Uroject12 Syringe Lever (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K190987 · Urogen Pharma, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
231d
Days
Class 2
Risk

K190987 is an FDA 510(k) clearance for the Uroject12 Syringe Lever. Classified as Piston Syringe Lever (product code QBL), Class II - Special Controls.

Submitted by Urogen Pharma, Ltd. (Ra’Anana, IL). The FDA issued a Cleared decision on December 2, 2019 after a review of 231 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 880.5860 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Urogen Pharma, Ltd. devices

Submission Details

510(k) Number K190987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2019
Decision Date December 02, 2019
Days to Decision 231 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 130d · This submission: 231d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QBL Piston Syringe Lever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition Controlled Compression Of A Piston Syringe
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.