510(k) Report

FDA applicant

Vance Products, Inc.

Mchenry, IL17 decisions1978–19826 recalls

FDA records 17 decisions for Vance Products, Inc. (Mchenry, IL) from 1978 to 1982: 17 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and KOE (Dilator, Urethral). 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Vance Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vance Products, Inc. since 2007.

Recalls per year

4in 2019

2010: 12019: 4
2007high 4 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vance Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vance Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KODCatheter, Urological5decisions
  • KOEDilator, Urethral4decisions
  • KOBCatheter, Suprapubic (And Accessories)2decisions
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology1decision
  • EZNDilator, Catheter, Ureteral1decision
  • GENForceps, General & Plastic Surgery1decision

Also: EXB (1), FGI (1), KNW (1).

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K812057Vance CystoscopicVance Products, Inc. · 19812cite it
  • K810372Vance Deflectable Biopsy Brush SetVance Products, Inc. · 19812cite it
  • K810368Vance Percutaneous Malecot NephrostomyVance Products, Inc. · 19811cites it
  • K813278Vpi Ureteral Dilatation Ballon CatheterVance Products, Inc. · 19811cites it
  • K820313Vpi-Fair Urethral StentVance Products, Inc. · 19821cites it

What has FDA decided for it lately?

  • K812995Vance-Jacobellis Microhematuria CatheterVance Products, Inc. · 1982
  • K820313Vpi-Fair Urethral StentVance Products, Inc. · 19821 recall
  • K813278Vpi Ureteral Dilatation Ballon CatheterVance Products, Inc. · 1981
  • K812785Vance-Ambrose Resectoscope ForcepsVance Products, Inc. · 1981
  • K812057Vance CystoscopicVance Products, Inc. · 1981
  • K811833Vnace Fascial Dilator SetVance Products, Inc. · 19812 recalls
  • K811454Vance Prostatic Aspiration SetVance Products, Inc. · 1981
  • K810367Kish Urethral Illuminated Catheter SetVance Products, Inc. · 1981

All 17 as Vance Products, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K810368Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr -…Apr 22, 2019Class II
  • K811833Urethral Dilator Set, Global Product No. G14185Jan 4, 2019Class II
  • K810368Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108Jan 4, 2019Class II
  • K810368Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329Jan 4, 2019Class II
  • K820313Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.Dec 13, 2010
  • K811833Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick…Aug 1, 2005