510(k) Report

FDA applicant

Johnson & Johnson Interventional Systems

Warren, NJ2 decisions1991–19910 recalls

FDA records 2 decisions for Johnson & Johnson Interventional Systems (Warren, NJ) in 1991: 2 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and DQY (Catheter, Percutaneous). No 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 Johnson & Johnson Interventional Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Johnson & Johnson Interventional Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Johnson”

FDA records each applicant name separately; these may or may not be the same firm.