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FDA 510(k)

RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE

K-Number: K032054 · 2003-09-15

ApplicantRadionics, A Division of Tyco Healthcare Group LP
Decision Date2003-09-15
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2003-09-15 under 510(k) number K032054. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE?

RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE is a medical device that received FDA 510(k) clearance on 2003-09-15. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. The 510(k) number is K032054.

When did RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE receive FDA 510(k) clearance?

RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE received FDA 510(k) clearance on 2003-09-15, under 510(k) number K032054.

Who is the listed applicant for RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE?

The FDA 510(k) record lists Radionics, A Division of Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE?

The FDA product code for RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE is HAW.

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Other records listing Radionics, A Division of Tyco Healthcare Group LP as applicant

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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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