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510(k) K051637

DSNARE, MODEL 00711087 by United States Endoscopy Group, Inc. — Product Code FCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2005
Date Received
June 20, 2005
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

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Other clearances for product code FCK

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  • K061201 — DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 (May 30, 2006)
  • 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)