510(k) Report

FDA applicant

Vpi

Walker, MI2 decisions1983–19841 recall

FDA records 2 decisions for Vpi (Walker, MI) from 1983 to 1984: 2 510(k) clearances. Most are in product codes LJE (Catheter, Nephrostomy) and FFL (Dislodger, Stone, Basket, Ureteral, Metal). 1 recall is 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 Vpi’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vpi since 2007.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • LJECatheter, Nephrostomy1decision
  • FFLDislodger, Stone, Basket, Ureteral, Metal1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K833762Percutaneous Retrograde NephrostomyVpi · 19842cite it
  • K831875Balloon Dilation Helical Stone ExtractVpi · 19831cites it

What has FDA decided for it lately?

  • K833762Percutaneous Retrograde NephrostomyVpi · 19841 recall
  • K831875Balloon Dilation Helical Stone ExtractVpi · 1983

All 2 as Vpi →

What has been recalled?

1 recall linked to its devices; the latest:

  • K833762Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649Jan 4, 2019Class II