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510(k) K800913

GYNECOLOGICAL CYSTO/URETHROSCOPE by Kli — Product Code FGC

K800913 is an FDA 510(k) premarket notification submitted by Kli for the device "GYNECOLOGICAL CYSTO/URETHROSCOPE". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code FGC (Urethroscope), a Class II device regulated under 21 CFR 876.1500. Kli has at least 10 other 510(k) clearances on record.

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)
  • K780955 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K780954 — 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)

FDA data resources