FDA applicant
Mr Surgical Solutions, LLC
FDA records 3 decisions for Mr Surgical Solutions, LLC (Conshohocken, PA) in 2025: 3 510(k) clearances. All are in product code SBF (Orthopedic Augmented Reality). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 Mr Surgical Solutions, LLC’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Mr Surgical Solutions, LLC’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