Cleared Traditional

K150434 - Injection Needle

K150434 is the FDA 510(k) clearance for Injection Needle by Micro-Tech (Nanjing) Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K150434 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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Jun 2015
Decision
103d
Days
Class 2
Risk

K150434 is an FDA 510(k) clearance for the Injection Needle. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on June 2, 2015 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 876.1500 - 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: 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 Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K150434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2015
Decision Date June 02, 2015
Days to Decision 103 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
27d faster than avg
Panel avg: 130d · This submission: 103d
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 46
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K150434.
Interject Injection Therapy Needle Catheter
K171454 · Boston Scientific Corporation · Jul 2017
Single Use Injector NM600/610
K153625 · Olympus Medical Systems Corp. · Feb 2016
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K152035 · United States Endoscopy Group, Inc. · Oct 2015
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