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510(k) K800913

GYNECOLOGICAL CYSTO/URETHROSCOPE by Kli — Product Code FGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 21, 1980
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 Kli

  • K800822 — CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE (June 17, 1980)
  • K781913 — INSUFFALATOR LAPARAOSCOPIC (December 4, 1978)
  • K781109 — FORCEPS, ELECTROSURGICAL (September 14, 1978)
  • K781089 — ONE INCISION BI-POLAR ELECTRO. FORCEPS (July 17, 1978)
  • K780954 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K780955 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K772297 — INSUFFLATOR, MODEL G100 & 200 (January 5, 1978)
  • K772242 — LAPAROSCOPY CONSOLE MODEL VIII (December 20, 1977)
  • K772220 — PROBE, COAGULATION ACCESSORY (December 13, 1977)
  • K772185 — LAPAROSCOPE W/REMOVABLE OPTICS (November 30, 1977)

Other clearances for product code FGC

  • K091600 — DIRECTVISION GUIDE SYSTEM (August 25, 2009)
  • K945907 — KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC E (May 12, 1995)