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510(k) K896385

URETERAL ACCESS SET by Applied Urology, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
November 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
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)
  • K905731 — FLEXIBLE ENDOSCOPIC ELECTRODE (January 31, 1991)
  • K903994 — URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION (October 19, 1990)

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