Cleared Special

K113634 - INJEKT CYSTO FLEXIBLE INJECTION NEEDLE

K113634 is the FDA 510(k) clearance for INJEKT CYSTO FLEXIBLE INJECTION NEEDLE by Cook Ireland, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Special 510(k) pathway after a 67-day FDA review.

K113634 · Cook Ireland, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
67d
Days
Class 2
Risk

K113634 is an FDA 510(k) clearance for the INJEKT CYSTO FLEXIBLE INJECTION NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on February 14, 2012 after a review of 67 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 Cook Ireland, Ltd. devices

Submission Details

510(k) Number K113634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2011
Decision Date February 14, 2012
Days to Decision 67 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
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

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 49
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K113634.
Single Use Injector NM600/610
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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