Cleared Traditional

K091391 - UROPLASTY RIGID ENDOSCOPIC NEEDLE

K091391 is an FDA 510(k) clearance for UROPLASTY RIGID ENDOSCOPIC NEEDLE, manufactured by Uroplasty, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K091391 · Uroplasty, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
50d
Days
Class 2
Risk

K091391 is an FDA 510(k) clearance for the UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Uroplasty, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 30, 2009 after a review of 50 days - a notably fast clearance cycle.

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: 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 Uroplasty, Inc. devices

FDA 510(k) Submission Details - K091391

510(k) Number K091391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2009
Decision Date June 30, 2009
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBK Device Classification - Class 2, Special Controls

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 52
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K091391.
INJECTION NEEDLE
K132065 · Endochoice, Inc. · Jan 2014
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
K113634 · Cook Ireland, Ltd. · Feb 2012
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
K111495 · Wilson-Cook Medical, Inc. · Jul 2011
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
K090217 · Coloplast A/S · Apr 2009
INJEKT FILIFORM INJECTION NEEDLE
K082319 · Cook Urological, Inc. · Sep 2008
TEGRESS IMPLANT NEEDLE
K050688 · C.R. Bard, Inc. · Apr 2005