FDA applicant
South Mountain Medical
FDA records 7 decisions for South Mountain Medical (Mchenry, IL) from 1981 to 1985: 7 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and GDY (Gauze/Sponge, Internal, X-Ray Detectable). 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 South Mountain Medical’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for South Mountain Medical since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like South Mountain Medical’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