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FDA 510(k)

RAPID STRAND RX

K-Number: K063177 · 2006-11-30

ApplicantOncura, Inc.
Decision Date2006-11-30
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAPID STRAND RX is the device name listed in this FDA 510(k) record. The listed applicant is Oncura, Inc.. It received FDA 510(k) clearance on 2006-11-30 under 510(k) number K063177. 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 RAPID STRAND RX?

RAPID STRAND RX is a medical device that received FDA 510(k) clearance on 2006-11-30. The listed applicant is Oncura, Inc.. The 510(k) number is K063177.

When did RAPID STRAND RX receive FDA 510(k) clearance?

RAPID STRAND RX received FDA 510(k) clearance on 2006-11-30, under 510(k) number K063177.

Who is the listed applicant for RAPID STRAND RX?

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

What is the FDA product code for RAPID STRAND RX?

The FDA product code for RAPID STRAND RX is KXK.

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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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