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510(k) K792220

VANCE KIDNEY BIOPSY BRUSHES by Vance Products, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 5, 1979
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 Vance Products, Inc.

  • K812995 — VANCE-JACOBELLIS MICROHEMATURIA CATHETER (March 1, 1982)
  • K820313 — VPI-FAIR URETHRAL STENT (March 1, 1982)
  • K813278 — VPI URETERAL DILATATION BALLON CATHETER (December 18, 1981)
  • K812785 — VANCE-AMBROSE RESECTOSCOPE FORCEPS (November 16, 1981)
  • K812057 — VANCE CYSTOSCOPIC (July 31, 1981)
  • K811833 — VNACE FASCIAL DILATOR SET (July 10, 1981)
  • K811454 — VANCE PROSTATIC ASPIRATION SET (June 9, 1981)
  • K810367 — KISH URETHRAL ILLUMINATED CATHETER SET (March 20, 1981)
  • K810371 — VANCE URETHAL DILATOR SET (March 20, 1981)
  • K810370 — POLLACK CHAIN CYSOURETHROGRAM SET (March 20, 1981)

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  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)