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FDA 510(k)

RADIONICS POLE NEEDLES

K-Number: K021942 · 2002-09-11

ApplicantRadionics, A Division of Tyco Healthcare Group LP
Decision Date2002-09-11
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RADIONICS POLE NEEDLES 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 2002-09-11 under 510(k) number K021942. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONICS POLE NEEDLES?

RADIONICS POLE NEEDLES is a medical device that received FDA 510(k) clearance on 2002-09-11. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. The 510(k) number is K021942.

When did RADIONICS POLE NEEDLES receive FDA 510(k) clearance?

RADIONICS POLE NEEDLES received FDA 510(k) clearance on 2002-09-11, under 510(k) number K021942.

Who is the listed applicant for RADIONICS POLE NEEDLES?

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 POLE NEEDLES?

The FDA product code for RADIONICS POLE NEEDLES is GXI.

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

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Related Devices (Code: GXI)

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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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