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510(k) K062159

RB12 SUCTION RECTAL BIOPSY SYSTEM by Aus Systems Pty , Ltd. — Product Code FCK

K062159 is an FDA 510(k) premarket notification submitted by Aus Systems Pty , Ltd. for the device "RB12 SUCTION RECTAL BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 5, 2006. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2006
Date Received
July 28, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy, Suction
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances for product code FCK

  • K153763 — Howell Biliary Aspiration Needle (April 6, 2017)
  • K103326 — MULTIPLE BIOPSY SYSTEM (April 6, 2011)
  • K061201 — DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 (May 30, 2006)
  • K051637 — DSNARE, MODEL 00711087 (October 31, 2005)
  • K954693 — MEHTA BRONCHIAL BIOSPY DRILL (October 23, 1995)
  • K944252 — BIOPSY DEVICE ACCESSORY (December 5, 1994)
  • K932142 — SUCTION GUILLOTINE DEVICE (September 24, 1993)
  • K911448 — MULTIPLE BIOPSY DEVICE-MBX (April 16, 1991)
  • K902910 — CYTOASPIRATOR (January 16, 1991)
  • K902097 — MODEL TR RECTAL SUCTION BIOPSY TUBE (July 27, 1990)

FDA data resources