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FDA 510(k)

RADIOACTIVE SEED LOCALIZATION NEEDLE

K-Number: K111979 · 2011-10-18

ApplicantBiocompatibles, Inc.
Decision Date2011-10-18
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOACTIVE SEED LOCALIZATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles, Inc.. It received FDA 510(k) clearance on 2011-10-18 under 510(k) number K111979. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOACTIVE SEED LOCALIZATION NEEDLE?

RADIOACTIVE SEED LOCALIZATION NEEDLE is a medical device that received FDA 510(k) clearance on 2011-10-18. The listed applicant is Biocompatibles, Inc.. The 510(k) number is K111979.

When did RADIOACTIVE SEED LOCALIZATION NEEDLE receive FDA 510(k) clearance?

RADIOACTIVE SEED LOCALIZATION NEEDLE received FDA 510(k) clearance on 2011-10-18, under 510(k) number K111979.

Who is the listed applicant for RADIOACTIVE SEED LOCALIZATION NEEDLE?

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

What is the FDA product code for RADIOACTIVE SEED LOCALIZATION NEEDLE?

The FDA product code for RADIOACTIVE SEED LOCALIZATION NEEDLE is KXK.

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Other records listing Biocompatibles, Inc. as applicant

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Related Devices (Code: KXK)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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