Vnace Fascial Dilator Set

• • Terminated Z-0971-2020 FDA Class II ·initiated 4 Jan 2019

  The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

• • Terminated Z-1584-05 FDA Unclassified (pre-2012) ·initiated 1 Aug 2005

  Mislabeled as to size.

510(k) Number

K811833 ↗

FDA Product Code

KOE

Device Class

Class II

Regulation

21 CFR Part 876.5520

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. →