Cleared Traditional

BACKSTOP AND BACKSTOP INJECTOR (K090430) - FDA 510(k) Clearance

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

K090430 · Pluromed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
103d
Days
Class 2
Risk

K090430 is an FDA 510(k) clearance for the BACKSTOP AND BACKSTOP INJECTOR. Classified as Dissolvable Gel For Preventing Ureteral Stone Migration (product code ONJ), Class II - Special Controls.

Submitted by Pluromed, Inc. (Woburn, US). The FDA issued a Cleared decision on June 2, 2009 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 Pluromed, Inc. devices

Submission Details

510(k) Number K090430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2009
Decision Date June 02, 2009
Days to Decision 103 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
27d faster than avg
Panel avg: 130d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONJ Dissolvable Gel For Preventing Ureteral Stone Migration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
Definition For Use In The Ureter To Prevent The Migration Of Urinary Calculi And Their Fragments During Intracorporeal Lithotripsy Procedures.
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.