Cleared Traditional

Williams Cystoscopic Injection Needle (K171602) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171602 · Cook Incorporated · Gastroenterology & Urology device
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Jul 2017
Decision
57d
Days
Class 2
Risk

K171602 is an FDA 510(k) clearance for the Williams Cystoscopic Injection Needle. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 28, 2017 after a review of 57 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 Cook Incorporated devices

Submission Details

510(k) Number K171602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date July 28, 2017
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
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 40
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K171602.
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
K190829 · Wilson-Cook Medical Inc./Cook Endoscopy · Dec 2019
Clear-Jet Injection Catheter
K181690 · Finemedix Co., Ltd. · Dec 2018
Repris Bladder Injection System
K180214 · Uro-1, Inc. · May 2018
Interject Injection Therapy Needle Catheter
K171454 · Boston Scientific Corporation · Jul 2017
Single Use Injector NM600/610
K153625 · Olympus Medical Systems Corp. · Feb 2016
iSnare system-Lariat
K152035 · United States Endoscopy Group, Inc. · Oct 2015