Cleared Traditional

K091417 - 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 is an FDA 510(k) clearance for SINGLE USE GUIDEWIRE, manufactured by Terumo Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K091417 · Terumo Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
9d
Days
Class 2
Risk

K091417 is an FDA 510(k) clearance for the SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-254.... Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on May 22, 2009 after a review of 9 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 Terumo Corp. devices

FDA 510(k) Submission Details - K091417

510(k) Number K091417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date May 22, 2009
Days to Decision 9 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
122d faster than avg
Panel avg: 131d · This submission: 9d
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 35
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K091417.
NEO ERCP GUIDEWIRE
K123439 · Neometrics, Inc. · Jan 2013
AXCESS SOFT TIP WIRE GUIDE
K122816 · Wilson-Cook Medical, Inc. · Oct 2012
XENX
K113692 · Xenolith Medical · Aug 2012
COOK WIRE GUIDES
K082536 · Cook Urological, Inc. · Oct 2008
TAXI ENDOSCOPIC GUIDEWIRE
K081708 · Lake Region Mfg., Inc. · Aug 2008
MANDREL GUIDEWIRES OR M-WIRE
K080508 · Lake Region Medical · Mar 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.