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510(k) K903994

URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION by Applied Urology, Inc. — Product Code FGF

K903994 is an FDA 510(k) premarket notification submitted by Applied Urology, Inc. for the device "URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION". The FDA issued a decision of Substantially Equivalent on October 19, 1990. The device falls under product code FGF (Catheter, Ureteral Disposable (X-Ray)), a Class II device regulated under 21 CFR 876.5130. Applied Urology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1990
Date Received
August 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral Disposable (X-Ray)
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)
  • K901214 — RIGID URETEROSCOPE (June 1, 1990)

FDA data resources