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510(k) K990334

KSEA ENDOSCOPE HOLDER by KARL STORZ Endoscopy-America, Inc. — Product Code OCV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1999
Date Received
February 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

To hold endoscope in a desired position during procedures.

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  • K960068 — SH-1 SURGICAL HOLDER FOR TELESCOPE (May 5, 1997)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)