510(k) Report

FDA applicant

B. Braun/Mcgaw

Bethlehem, PA2 decisions1999–20001 recall

FDA records 2 decisions for B. Braun/Mcgaw (Bethlehem, PA) from 1999 to 2000: 2 510(k) clearances. Most are in product codes KNQ (Dilator, Esophageal) and LJT (Port & Catheter, Implanted, Subcutaneous…). 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 B. Braun/Mcgaw’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for B. Braun/Mcgaw since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — B. Braun/Mcgaw 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?

  • KNQDilator, Esophageal1decision
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K994111Celsite, Models ST401L, ST405LB. Braun/Mcgaw · 20001cites it

What has FDA decided for it lately?

  • K994111Celsite, Models ST401L, ST405LB. Braun/Mcgaw · 2000
  • K983373Impact Balloon Dilation CatheterB. Braun/Mcgaw · 19991 recall

All 2 as B. Braun/Mcgaw →

What has been recalled?

1 recall linked to its devices; the latest:

  • K931009IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number…Sep 23, 2009