Cleared Special

K122816 - AXCESS SOFT TIP WIRE GUIDE

K122816 is an FDA 510(k) clearance for AXCESS SOFT TIP WIRE GUIDE, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Special 510(k) pathway after a 25-day FDA review.

K122816 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
25d
Days
Class 2
Risk

K122816 is an FDA 510(k) clearance for the AXCESS SOFT TIP WIRE GUIDE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on October 9, 2012 after a review of 25 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 Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K122816

510(k) Number K122816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2012
Decision Date October 09, 2012
Days to Decision 25 days
Submission Type Special
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
106d faster than avg
Panel avg: 131d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

OCY Device Classification - Class 2, Special Controls

Product Code OCY Endoscopic Guidewire, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.
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 - OCY Endoscopic Guidewire, Gastroenterology-urology

All 33
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K122816.
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
K131072 · Coloplast A/S · Jul 2013
OSTAVI HYDROPHILIC GUIDEWIRE
K124052 · Lake Region Medical · Feb 2013
NEO ERCP GUIDEWIRE
K123439 · Neometrics, Inc. · Jan 2013
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
K091417 · Terumo Corp. · May 2009
COOK WIRE GUIDES
K082536 · Cook Urological, Inc. · Oct 2008
TAXI ENDOSCOPIC GUIDEWIRE
K081708 · Lake Region Mfg., Inc. · Aug 2008