Cleared Traditional

K170741 - GTK Disposable Needle Guides

K170741 is an FDA 510(k) clearance for GTK Disposable Needle Guides, manufactured by Geotek Medikal Ltd Sti. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K170741 · Geotek Medikal Ltd Sti · Radiology device
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Jun 2017
Decision
83d
Days
Class 2
Risk

K170741 is an FDA 510(k) clearance for the GTK Disposable Needle Guides. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Geotek Medikal Ltd Sti (Ankara, TR). The FDA issued a Cleared decision on June 1, 2017 after a review of 83 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 Geotek Medikal Ltd Sti devices

FDA 510(k) Submission Details - K170741

510(k) Number K170741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2017
Decision Date June 01, 2017
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

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 Consultant

Licensale, Inc.
Raymond Kelly

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 - ITX Transducer, Ultrasonic, Diagnostic

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