FDA applicant
Gl Ultrasound, Ltd.
FDA records 3 decisions for Gl Ultrasound, Ltd. (Livingston W.Lothian, GB) from 1985 to 1986: 3 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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 Gl Ultrasound, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Gl Ultrasound, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Gl Ultrasound, 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