FDA 510(k)

RB12 SUCTION RECTAL BIOPSY SYSTEM

K-Number: K062159 · 2006-09-05

Decision Date2006-09-05

Product CodeFCK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RB12 SUCTION RECTAL BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aus Systems Pty , Ltd.. It received FDA 510(k) clearance on 2006-09-05 under 510(k) number K062159. The device is classified under product code FCK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RB12 SUCTION RECTAL BIOPSY SYSTEM?

RB12 SUCTION RECTAL BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-05. The listed applicant is Aus Systems Pty , Ltd.. The 510(k) number is K062159.

When did RB12 SUCTION RECTAL BIOPSY SYSTEM receive FDA 510(k) clearance?

RB12 SUCTION RECTAL BIOPSY SYSTEM received FDA 510(k) clearance on 2006-09-05, under 510(k) number K062159.

Who is the listed applicant for RB12 SUCTION RECTAL BIOPSY SYSTEM?

The FDA 510(k) record lists Aus Systems Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RB12 SUCTION RECTAL BIOPSY SYSTEM?

The FDA product code for RB12 SUCTION RECTAL BIOPSY SYSTEM is FCK.

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Related Devices (Code: FCK)

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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.