FDA applicant
Gt Metabolic Solutions, Inc.
FDA records 5 decisions for Gt Metabolic Solutions, Inc. (San Jose, CA) from 2024 to 2026: 4 510(k) clearances and 1 De Novo grant. All are in product code SAH (Magnetic Compression Anastomosis System). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 7 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 Gt Metabolic Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Gt Metabolic Solutions, Inc.’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