FCKClass II

Instrument, Biopsy, Suction

Gastroenterology, Urology · 21 CFR 876.1075

MDR events16All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances13All time

Recent MDR events

16 adverse event reports on file

RBI2 SUCTION RECTAL BIOPSY SYSTEMMay 17, 2025
MalfunctionAus Systems Pty Ltd3005921952-2025-00001
RBI2 SUCTION RECTAL BIOPSY SYSTEMDec 14, 2024
MalfunctionAus Systems Pty Ltd3005921952-2024-00006
RBI2 SUCTION RECTAL BIOPSY SYSTEMDec 14, 2024
MalfunctionAus Systems Pty Ltd3005921952-2024-00005
RBI2 SUCTION RECTAL BIOPSY SYSTEMDec 13, 2024
MalfunctionAus Systems Pty Ltd3005921952-2024-00004
RBI2 SUCTION RECTAL BIOPSY SYSTEMNov 18, 2024
MalfunctionAus Systems Pty. Limited.20705393
RBI2 SUCTION RECTAL BIOPSY SYSTEMNov 18, 2024
MalfunctionAus Systems Pty. Limited.20705444
RBI2 SUCTION RECTAL BIOPSY SYSTEMNov 12, 2024
MalfunctionAus Systems Pty. Limited.20662499
PROCEDURE PACK (CUTTER)Jan 26, 2024
MalfunctionAus Systems Pty Ltd18586574
RBI2 SUCTION RECTAL BIOPSY SYSTEMMar 2, 2022
InjuryAus Systems Pty Ltd3005921952-2022-00001
RB12 SUCTION RECTAL BIOPSY MANOMETERFeb 23, 2022
InjuryAus Systems Pty Ltd.MW5107662

Event type breakdown

Malfunction10

Injury6

Most-reported manufacturers

Aus Systems Pty Ltd6 Unspecified3 Aus Systems Pty. Limited.3 Aus Systems Pty Ltd.2 Bard Peripheral Vascular Inc1 Ethicon-endo Surgery, Inc.1

Recalls

1 recall events for this product code

Bard Peripheral Vascular Inc
TerminatedDec 2, 2011
The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems.
This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked EnCor (Trademark) packaging trays, plastic PETG tray the probe is packaged in was cracked.
Z-0351-2012 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

13 clearances for this product code