Cleared Traditional

K150927 - Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff

K150927 is an FDA 510(k) clearance for Orchestra Hydrophilic Guidewire standar..., manufactured by Coloplast A/S. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K150927 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
51d
Days
Class 2
Risk

K150927 is an FDA 510(k) clearance for the Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidew.... Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on May 27, 2015 after a review of 51 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.

FDA 510(k) Submission Details - K150927

510(k) Number K150927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2015
Decision Date May 27, 2015
Days to Decision 51 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
80d faster than avg
Panel avg: 131d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 42
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K150927.
EasyPass Guidewire
K153264 · Medi-Globe Corporation · May 2016
Radifocus Glidewire Endoscopic Wire
K151471 · Terumo Medical Corporation · Sep 2015
NovaGold High Performance Guidewire
K150225 · Neometrics, Inc. · Mar 2015
Acrobat Calibrated Tip Wire Guide
K142950 · Wilson-Cook Medical, Inc. · Nov 2014
JAGWIRE HIGH PERFORMANCE GUIDWIRE
K141820 · Boston Scientific Corp · Oct 2014
Predicate III Guidewire
K142397 · Lake Region Medical · Sep 2014
K150927 · Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
Download PDF FDA Summary Coloplast A/S