GI Windows Surgical Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3021969326 | 3021969326 | GI Windows Surgical Inc. | 1 | N | 2026-01-01 | 480 Neponset St Ste 11b1 Canton MA US 02021 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 328562 | 1127759560 | K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | SAH | 2026-01-09 |
| 328562 | 1194187862 | K243482 | Self-Forming Magnet (Flexagon) | SAH | 2025-06-11 |
| 328562 | 1053403422 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| SAH | 2 | 2026-01-09 |