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510(k) K915219

URETHRAL ELECTRODE SHEATH by Applied Urology, Inc. — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1992
Date Received
November 20, 1991
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)
  • 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)
  • K905731 — FLEXIBLE ENDOSCOPIC ELECTRODE (January 31, 1991)
  • K903994 — URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION (October 19, 1990)
  • K901214 — RIGID URETEROSCOPE (June 1, 1990)

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