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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

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 the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2017-08-04 under 510(k) 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. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K171596.

When did ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Wilson-Cook Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 34 devices →

Related Devices (Code: FCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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