Vance Percutaneous Malecot Nephrostomy

• • Terminated Z-1370-2019 FDA Class II ·initiated 22 Apr 2019

  Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.

• 2 recalls, same reason

  • Terminated Z-0969-2020 FDA Class II ·initiated 4 Jan 2019
  • Terminated Z-0968-2020 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.

510(k) Number

K810368 ↗

FDA Product Code

KOB

Device Class

Class II

Regulation

21 CFR Part 876.5090

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. →

• What is the VANCE PERCUTANEOUS MALECOT NEPHROSTOMY device intended for?

  The VANCE PERCUTANEOUS MALECOT NEPHROSTOMY is a percutaneous nephrostomy device designed for drainage access, as defined by its classification as a catheter, suprapubic (and accessories). It is intended for use in gastroenterology and urology specialties to provide urinary drainage when normal pathways are obstructed.

• How was the VANCE PERCUTANEOUS MALECOT NEPHROSTOMY cleared for market distribution?

  The device was cleared via the FDA 510(k) process under submission K810368, receiving a substantially equivalent decision on March 20, 1981. This traditional 510(k) clearance pathway was used to demonstrate substantial equivalence to a legally marketed predicate device.

• What regulatory classification and product code apply to the VANCE PERCUTANEOUS MALECOT NEPHROSTOMY?

  The device is classified as Class II under regulation number 876.5090 and is assigned product code KOB. These classifications reflect its categorization as a catheter, suprapubic (and accessories) for percutaneous nephrostomy drainage access.