510(k) clearance

GI Windows Flexagon Plus OTOLoc System

FDA 510(k) source

510(k) number

K261630

Applicant

GI Windows Surgical

Decision date

Oct 28, 2026

Date received

May 18, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

SAH

Device type

Magnetic Compression Anastomosis System

Device class

Class II

Regulation

21 CFR 878.4816

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Canton, MA, US