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510(k) K030194

XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT by The Olympus Optical Co. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2003
Date Received
January 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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  • K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
  • K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
  • K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)
  • K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (May 15, 2001)

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