Cleared Special

K203321 - Cystoject Syringe Lever (FDA 510(k) Clearance)

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

K203321 · Urogen Pharma, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
27d
Days
Class 2
Risk

K203321 is an FDA 510(k) clearance for the Cystoject 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 9, 2020 after a review of 27 days - a notably fast clearance 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. Low regulatory complexity profile. 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 K203321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2020
Decision Date December 09, 2020
Days to Decision 27 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
103d faster than avg
Panel avg: 130d · This submission: 27d
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.