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FDA 510(k)

ECHOTIP(R) ULTRA FIDUCIAL NEEDLE

K-Number: K111895 · 2012-04-27

ApplicantWilson-Cook Medical Inc./Cook Endoscopy
Decision Date2012-04-27
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECHOTIP(R) ULTRA FIDUCIAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2012-04-27 under 510(k) number K111895. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOTIP(R) ULTRA FIDUCIAL NEEDLE?

ECHOTIP(R) ULTRA FIDUCIAL NEEDLE is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K111895.

When did ECHOTIP(R) ULTRA FIDUCIAL NEEDLE receive FDA 510(k) clearance?

ECHOTIP(R) ULTRA FIDUCIAL NEEDLE received FDA 510(k) clearance on 2012-04-27, under 510(k) number K111895.

Who is the listed applicant for ECHOTIP(R) ULTRA FIDUCIAL NEEDLE?

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

What is the FDA product code for ECHOTIP(R) ULTRA FIDUCIAL NEEDLE?

The FDA product code for ECHOTIP(R) ULTRA FIDUCIAL NEEDLE is NEU.

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Other records listing Wilson-Cook Medical Inc./Cook Endoscopy 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.

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Related Devices (Code: NEU)

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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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