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510(k) K934730

KARL STORZ ENDOSCOPIC COLD KNIFE BLADES by KARL STORZ Endoscopy-America, Inc. — Product Code EZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1994
Date Received
October 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urethrotome
Device Class
Class II
Regulation Number
876.4770
Review Panel
GU
Submission Type

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  • K191357 — Flexible HD Cysto-Urethroscope System (September 18, 2019)
  • K182723 — Flexible HD Cysto-Urethroscope System (April 23, 2019)
  • K182186 — CMOS Video-Rhino-Laryngoscope System (March 22, 2019)
  • K183264 — Flex-THOR scope (January 18, 2019)

Other clearances for product code EZO

  • K000905 — URETHROTOME 8667.XXX AND 8670.XXX (May 12, 2000)
  • K950719 — OES UROLOGY (December 11, 1996)
  • K945686 — KARL STORZ KNIVES, CURETTES (February 13, 1995)
  • K904939 — FLEXIBLE AND RIGID URETEROTOME SYSTEM (January 7, 1992)