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FDA 510(k)

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle

K-Number: K171596 · 2017-08-04

ApplicantWilson-Cook Medical, Inc.
Decision Date2017-08-04
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2017-08-04 under approval number K171596. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle?

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle is a medical device that received FDA 510(k) clearance on 2017-08-04. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K171596.

When was ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle approved by the FDA?

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle received FDA 510(k) clearance on 2017-08-04, under approval number K171596.

What company makes ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle?

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle?

The FDA product code for ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle is FCG.

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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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