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510(k) K905731

FLEXIBLE ENDOSCOPIC ELECTRODE by Applied Urology, Inc. — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1991
Date Received
December 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Applied Urology, Inc.

  • K921838 — ACUCISE URETERAL CUTTING CATHETER (February 26, 1993)
  • K925282 — UROLOGICAL CATHETER AND ACCESSORIES (January 13, 1993)
  • K920695 — URETERAL STENT (September 23, 1992)
  • K915219 — URETHRAL ELECTRODE SHEATH (July 23, 1992)
  • K912093 — DISPOSABLE ASPIRATION IRRIGATION SYSTEM (April 24, 1992)
  • K920030 — SURESEAL ENDOSCOPIC VALVE (March 18, 1992)
  • K912656 — ENDOSCOPIC ELECTRODE (September 16, 1991)
  • K912903 — PERCUTANEOUS RETRACTOR KIT (August 16, 1991)
  • K903994 — URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION (October 19, 1990)
  • K901214 — RIGID URETEROSCOPE (June 1, 1990)

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