Home / 510(k) Clearances / K945907

510(k) K945907

KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES by KARL STORZ Endoscopy-America, Inc. — Product Code FGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1995
Date Received
December 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by KARL STORZ Endoscopy-America, Inc.

  • 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)
  • K182696 — Telepack X LED (November 20, 2018)

Other clearances for product code FGC

  • K091600 — DIRECTVISION GUIDE SYSTEM (August 25, 2009)
  • K800913 — GYNECOLOGICAL CYSTO/URETHROSCOPE (May 14, 1980)