Cleared Traditional

K090217 - BONEE NEEDLE FOR BLADDER INJECTIONS

K090217 is the FDA 510(k) clearance for BONEE NEEDLE FOR BLADDER INJECTIONS by Coloplast A/S. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K090217 · Coloplast A/S · Gastroenterology & Urology device
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Apr 2009
Decision
84d
Days
Class 2
Risk

K090217 is an FDA 510(k) clearance for the BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on April 23, 2009 after a review of 84 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 Coloplast A/S devices

Submission Details

510(k) Number K090217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2009
Decision Date April 23, 2009
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K090217.
Single Use Injector NM600/610
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K111495 · Wilson-Cook Medical, Inc. · Jul 2011
INJEKT FILIFORM INJECTION NEEDLE
K082319 · Cook Urological, Inc. · Sep 2008
TEGRESS IMPLANT NEEDLE
K050688 · C.R. Bard, Inc. · Apr 2005
ENTERYX INJECTION CATHETER
K042882 · Boston Scientific Corp · Nov 2004