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FDA 510(k)

GTK Disposable Needle Guides

K-Number: K170741 · 2017-06-01

ApplicantGeotek Medikal Ltd Sti
Decision Date2017-06-01
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GTK Disposable Needle Guides is a medical device manufactured by Geotek Medikal Ltd Sti. It received FDA 510(k) clearance on 2017-06-01 under approval number K170741. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GTK Disposable Needle Guides?

GTK Disposable Needle Guides is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Geotek Medikal Ltd Sti. The 510(k) number is K170741.

When was GTK Disposable Needle Guides approved by the FDA?

GTK Disposable Needle Guides received FDA 510(k) clearance on 2017-06-01, under approval number K170741.

What company makes GTK Disposable Needle Guides?

GTK Disposable Needle Guides is manufactured by Geotek Medikal Ltd Sti.

What is the FDA product code for GTK Disposable Needle Guides?

The FDA product code for GTK Disposable Needle Guides is ITX.

Other Devices by Geotek Medikal Ltd Sti

K223300Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument

Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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