GI WINDOWS

FDA Device Registration & Listing · Canton, MA, US · Registration 3021969326

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021969326
FEI Number
3021969326
Entity Name
GI WINDOWS
City/State/Country
Canton, MA, US
Establishment Address
480 Neponset St Ste 11b1, Canton, MA 02021, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
GI Windows (Owner Number: 10090756)
Owner / Operator Contact Address
480 Neponset St., Ste. 11B1, Canton, MA 02021, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Flexagon SFM System Titanium Grasper

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SAH Magnetic Compression Anastomosis System General, Plastic Surgery Class 2 878.4816 2025-09-02
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-05-09

Official Correspondent

Yverre Bobay

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GI Windows
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K253550 GI Windows, Inc. Self-Forming Magnet (Flexagon Plus OTOLoc) 2026-01-09
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021969326. Last updated year: 2026. Please use registration number 3021969326 when referencing this establishment in official correspondence.
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