Cleared Traditional

K051905 - UROPLASTY RIGID ENDOSCOPIC NEEDLE

K051905 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 46-day FDA review.

K051905 · Uroplasty, Inc. · Gastroenterology & Urology device
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Aug 2005
Decision
46d
Days
Class 2
Risk

K051905 is an FDA 510(k) clearance for the UROPLASTY RIGID ENDOSCOPIC NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Uroplasty, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 29, 2005 after a review of 46 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 - K051905

510(k) Number K051905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2005
Decision Date August 29, 2005
Days to Decision 46 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
85d faster than avg
Panel avg: 131d · This submission: 46d
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 73
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K051905.
INJEKT FILIFORM INJECTION NEEDLE
K082319 · Cook Urological, Inc. · Sep 2008
INJECTRA INJECTION NEEDLE
K061222 · Medi-Globe Corp. · Jul 2006
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
K043383 · Physion, Inc. · Oct 2005
TEGRESS IMPLANT NEEDLE
K050688 · C.R. Bard, Inc. · Apr 2005
ENTERYX INJECTION CATHETER
K042882 · Boston Scientific Corp · Nov 2004
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
K042615 · Carbon Medical Technologies, Inc. · Nov 2004