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510(k) K945686

KARL STORZ KNIVES, CURETTES by KARL STORZ Endoscopy-America, Inc. — Product Code EZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1995
Date Received
November 21, 1994
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

Other clearances by KARL STORZ Endoscopy-America, Inc.

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  • K223923 — HOPKINS Telescopes (March 30, 2023)
  • K202957 — Flexible Video Cysto-Urethroscope (C-view) (October 29, 2020)
  • K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver (October 22, 2020)
  • K201135 — Image1 S CCU, Image1 S 4U Camera Head (September 1, 2020)
  • K200740 — HD Video Rhino Laryngoscope (August 11, 2020)
  • 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)
  • K934730 — KARL STORZ ENDOSCOPIC COLD KNIFE BLADES (January 11, 1994)
  • K904939 — FLEXIBLE AND RIGID URETEROTOME SYSTEM (January 7, 1992)