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510(k) K911448

MULTIPLE BIOPSY DEVICE-MBX by Triton Technology, Inc. — Product Code FCK

K911448 is an FDA 510(k) premarket notification submitted by Triton Technology, Inc. for the device "MULTIPLE BIOPSY DEVICE-MBX". The FDA issued a decision of Substantially Equivalent on April 16, 1991. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. Triton Technology, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1991
Date Received
March 15, 1991
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 by Triton Technology, Inc.

  • K932142 — SUCTION GUILLOTINE DEVICE (September 24, 1993)
  • K902883 — TISSUE/POLYP TRAP SYSTEM (September 12, 1990)
  • K881303 — TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER (November 29, 1988)

Other clearances for product code FCK

  • K153763 — Howell Biliary Aspiration Needle (April 6, 2017)
  • K103326 — MULTIPLE BIOPSY SYSTEM (April 6, 2011)
  • K062159 — RB12 SUCTION RECTAL BIOPSY SYSTEM (September 5, 2006)
  • 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)
  • K902910 — CYTOASPIRATOR (January 16, 1991)
  • K902097 — MODEL TR RECTAL SUCTION BIOPSY TUBE (July 27, 1990)

FDA data resources