510(k) Report

FDA applicant

Uresil Corp.

Skokie, IL49 decisions1981–20100 recalls

FDA records 49 decisions for Uresil Corp. (Skokie, IL) from 1981 to 2010: 49 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and LJE (Catheter, Nephrostomy). No recall is linked to its devices.

FDA’s records also spell it “Uresil, LLC”, “Uresil, L.P.”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Uresil Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts7decisions
  • LJECatheter, Nephrostomy5decisions
  • GBOCatheter, Nephrostomy, General & Plastic Surgery3decisions
  • DQYCatheter, Percutaneous3decisions
  • HETLaparoscope, Gynecologic (And Accessories)2decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions

Also: DRE (2), DXE (2), GBS (2), EXF (2), GCY (2), DWQ (1).

Who builds on its devices?

Later devices cite its devices 6 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.

  • K930011Uresil Valve Cutter with Interchangeable HeadsUresil Corp. · 19932cite it
  • K053245GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter; Biliary CatheterUresil, LLC · 20051cites it
  • K914699Uresil Fixation DeviceUresil Corp. · 19921cites it
  • K003753GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP General Purpose…Uresil Corp. · 20011cites it
  • K981344Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingUresil Corp. · 19981cites it

What has FDA decided for it lately?

  • K093653Uresil Gastrostomy Catheter Kit , Model GCL-630HBKUresil, LLC · 2010
  • K053245GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter; Biliary CatheterUresil, LLC · 2005
  • K041995Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter, Nephrostomy Catheter…Uresil, LLC · 2004
  • K021632GP General Purpose Drainage Catheter; Mini-Pigtail Drainage Catheter with Locking Pigtail; GP General…Uresil, L.P. · 2002
  • K003753GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP General Purpose…Uresil Corp. · 2001
  • K980278Uresil Vascu-Flo Infusion CatheterUresil Corp. · 1998
  • K981344Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingUresil Corp. · 1998
  • K980282Uresil Dilator with Radiopaque MarkerUresil Corp. · 1998

All 45 as Uresil Corp. →All 3 as Uresil, LLC →The one decision as Uresil, L.P. →