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510(k) K954050

RESECTOSCOPES by KARL STORZ Endoscopy-America, Inc. — Product Code FJL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1995
Date Received
August 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K042523 — RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSOR (March 18, 2005)
  • K041610 — MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (August 19, 2004)