FDA applicant
Endogastric Solutions, Inc.
FDA records 11 decisions for Endogastric Solutions, Inc. (Redmond, WA) from 2007 to 2024: 11 510(k) clearances. Most are in product codes ODE (Endoscopic Suture/Plication System…) and OCW (Endoscopic Tissue Approximation Device). Its devices cite 19 predicates, 13 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Endogastric Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Endogastric 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