Cleared Traditional

K043425 - SHEATHES NEEDLE GUIDE

K043425 is the FDA 510(k) clearance for SHEATHES NEEDLE GUIDE by Sheathing Technologies, Inc.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K043425 · Sheathing Technologies, Inc. · Radiology device
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Feb 2005
Decision
77d
Days
Class 2
Risk

K043425 is an FDA 510(k) clearance for the SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUM.... Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Sheathing Technologies, Inc. (Morgan Hill, US). The FDA issued a Cleared decision on February 28, 2005 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight 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 Sheathing Technologies, Inc. devices

Submission Details

510(k) Number K043425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2004
Decision Date February 28, 2005
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

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