FDA applicant
Electrocaine Medical System
FDA records 5 decisions for Electrocaine Medical System (Lancaster, PA) from 1980 to 1993: 5 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and BZG (Spirometer, Diagnostic). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Electrocaine Medical System’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Electrocaine Medical System since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Electrocaine Medical System’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report