FDA applicant
GI Windows, Inc.
FDA records 4 decisions for GI Windows, Inc. (Westwood, MA) from 2025 to 2026: 4 510(k) clearances. All are in product code SAH (Magnetic Compression Anastomosis System). Since 2016 its 510(k)s took a median of 138 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 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 GI Windows, Inc.’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 GI Windows, 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