Data / Medical devices / United States / GI Windows Surgical Inc.
GI Windows Surgical Inc.: FDA-registered device maker in Canton, MA, United States, 2 510(k) clearances
GI Windows Surgical Inc. is registered with the FDA (registration 3021969326) in Canton, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 9, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3021969326
- Address
- 480 Neponset St Ste 11b1, Canton, MA, United States, 02021
- Owner or operator
- GI Windows (10090756)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 9, 2024
- Registered through
- 2026
- Brand names listed
- Flexagon SFM Plus OTOLoc System (FlexFie Universal Laparoscopic Delivery), Flexagon SFM System, Titanium Grasper
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Magnetic Compression Anastomosis System | SAH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 9, 2026 | K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | SAH | Substantially Equivalent | GI Windows, Inc. | accessdata.fda.gov |
| June 11, 2025 | K243482 | Self-Forming Magnet (Flexagon) | SAH | Substantially Equivalent | GI Windows, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.