FDA applicant
Vacurect Manufacturing (Pty), Ltd.
FDA records 2 decisions for Vacurect Manufacturing (Pty), Ltd. (North Attleboro, MA) from 2002 to 2003: 2 510(k) clearances. All are in product code LKY (Device, External Penile Rigidity). Its devices cite 4 predicates, 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
How often FDA has decided Vacurect Manufacturing (Pty), Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Vacurect Manufacturing (Pty), Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Vacurect Manufacturing (Pty), Ltd.’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