Cleared Special

K002323 - ADVANCED UROSCIENCE INJECTION NEEDLE

K002323 is an FDA 510(k) clearance for ADVANCED UROSCIENCE INJECTION NEEDLE, manufactured by Advanced Uroscience, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Special 510(k) pathway after a 34-day FDA review.

K002323 · Advanced Uroscience, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
34d
Days
Class 2
Risk

K002323 is an FDA 510(k) clearance for the ADVANCED UROSCIENCE INJECTION NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Advanced Uroscience, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 31, 2000 after a review of 34 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. 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 Advanced Uroscience, Inc. devices

FDA 510(k) Submission Details - K002323

510(k) Number K002323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2000
Decision Date July 31, 2000
Days to Decision 34 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
96d faster than avg
Panel avg: 130d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

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 K002323.
TEGRESS IMPLANT NEEDLE
K050688 · C.R. Bard, Inc. · Apr 2005
ENTERYX INJECTION CATHETER
K042882 · Boston Scientific Corp · Nov 2004
COOK INJECTION NEEDLE
K022484 · Cook Urological, Inc. · Oct 2002
NEEDLE CATHETER
K961846 · Boston Scientific Corp · Jul 1996
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
K954519 · Mill-Rose Laboratory · Dec 1995
INJECTION NEEDLE
K953338 · Boston Scientific Corp · Aug 1995