Cleared Traditional

K123439 - NEO ERCP GUIDEWIRE

K123439 is an FDA 510(k) clearance for NEO ERCP GUIDEWIRE, manufactured by Neometrics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K123439 · Neometrics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jan 2013
Decision
56d
Days
Class 2
Risk

K123439 is an FDA 510(k) clearance for the NEO ERCP GUIDEWIRE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 3, 2013 after a review of 56 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 Neometrics, Inc. devices

FDA 510(k) Submission Details - K123439

510(k) Number K123439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2012
Decision Date January 03, 2013
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 131d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K123439.
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
K133076 · Neometrics, Inc. · Feb 2014
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
AXCESS SOFT TIP WIRE GUIDE
K122816 · Wilson-Cook Medical, Inc. · Oct 2012
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

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.