GTK Disposable Needle Guides

FDA 510(k) K170741 · Geotek Medikal Ltd Sti

Substantially Equivalent

510(k) numberK170741

Submission

Device name
GTK Disposable Needle Guides
Applicant
Geotek Medikal Ltd Sti
Ankara, TR
Received
March 10, 2017
Decision date
June 1, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

When was GTK Disposable Needle Guides cleared by the FDA?

GTK Disposable Needle Guides (K170741) received a 510(k) decision of Substantially Equivalent on June 1, 2017, 83 days after the submission was received.

What is the product code of K170741?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.