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510(k) K902910

CYTOASPIRATOR by H & B Medical Technology, Inc. — Product Code FCK

K902910 is an FDA 510(k) premarket notification submitted by H & B Medical Technology, Inc. for the device "CYTOASPIRATOR". The FDA issued a decision of Substantially Equivalent on January 16, 1991. 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
January 16, 1991
Date Received
July 2, 1990
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)
  • 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)
  • K911448 — MULTIPLE BIOPSY DEVICE-MBX (April 16, 1991)
  • K902097 — MODEL TR RECTAL SUCTION BIOPSY TUBE (July 27, 1990)

FDA data resources