Vpi-Fair Urethral Stent

• • Terminated Z-0966-2011 FDA Unclassified (pre-2012) ·initiated 13 Dec 2010

  The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch.

510(k) Number

K820313 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Vance Cystoscopic

  Class II

  FDA 510(k) K812057 Active Cleared 31 Jul 1981

• Vance Kidney Biopsy Brushes

  Class II

  FDA 510(k) K792220 Active Cleared 6 Dec 1979

• Vance Urostomy Appliance

  Class I

  FDA 510(k) K803048 Active Cleared 22 Dec 1980

• Pollack Chain Cysourethrogram Set

  Class II

  FDA 510(k) K810370 Active Cleared 20 Mar 1981

• Vance-Ambrose Resectoscope Forceps

  Class I

  FDA 510(k) K812785 Active Cleared 16 Nov 1981

• Vance Philips Follower Catheter & Bougie

  Class II

  FDA 510(k) K792221 Active Cleared 6 Dec 1979

See all devices from Vance Products, Inc. →