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510(k) K023272

DISPOSABLE ASPIRATION NEEDLE NA-200H by The Olympus Optical Co. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2002
Date Received
October 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by The Olympus Optical Co.

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  • K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SE (January 31, 2003)
  • K023767 — UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES (November 29, 2002)
  • K012074 — XBO1-824-18/19/20 BIOPSY FORCEPS (September 25, 2001)
  • K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
  • K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
  • K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (May 15, 2001)
  • K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)

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