510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K062159Substantially Equivalent

Rb12 Suction Rectal Biopsy System

Aus Systems Pty Ltd., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062159 is the FDA 510(k) clearance record for RB12 SUCTION RECTAL BIOPSY SYSTEM, a class II device, cleared for Aus Systems Pty , Ltd. on under FDA product code FCK (Instrument, Biopsy, Suction). FDA records list one 510(k) clearance for Aus Systems Pty , Ltd. As of , FDA records show no recalls naming K062159.

Clearance record

Decision date
Received
(39 days to decision)
Product code
FCK Instrument, Biopsy, Suction
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Aus Systems Pty , Ltd. 2454 Mcmullen Booth Rd., Clearwater FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCK

Trailing 12 months

FDA records hold no clearances under product code FCK in the trailing twelve months.

FDA records show no clearances under product code FCK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260