Cleared Traditional

K914358 - ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP

K914358 is the FDA 510(k) clearance for ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP by Hobbs Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EYB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K914358 · Hobbs Medical, Inc. · Gastroenterology & Urology device
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Nov 1991
Decision
49d
Days
Class 2
Risk

K914358 is an FDA 510(k) clearance for the ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Hobbs Medical, Inc. devices

Submission Details

510(k) Number K914358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date November 19, 1991
Days to Decision 49 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EYB Catheter, Ureteral, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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.