510(k) Report

FDA applicant

Jbw7 Innovations, LLC

Southfield, MI1 decision2016–20160 recalls

FDA records 1 decision for Jbw7 Innovations, LLC (Southfield, MI) in 2016: 1 510(k) clearance. All are in product code LJE (Catheter, Nephrostomy). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Jbw7 Innovations, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Jbw7 Innovations, LLC by year, 2016–2026Sources: 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

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K160077RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture SetJbw7 Innovations, LLC · 2016

The one decision as Jbw7 Innovations, LLC →