Self-Forming Magnet (Flexagon Plus OTOLoc)— 510(k) K253550

Name: FDA 510(k) clearance K253550
Creator: U.S. Food and Drug Administration
Published: 2026-01-09

Substantially Equivalent

GI Windows, Inc.

FDA 510(k) clearance K253550 for Self-Forming Magnet (Flexagon Plus OTOLoc), Substantially Equivalent on 2026-01-09. Applicant: GI Windows, Inc.. Device class: 2.

Clearance details

Applicant: GI Windows, Inc.
Product code: Code SAH
Device class: Class 2
Regulation: 21 CFR 878.4816
Advisory panel: General, Plastic Surgery
Date received: 2025-11-14
Decision date: 2026-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SAH

view all

K253102 — GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)2026-06-04
K250541 — Self-Forming Magnet (Flexagon Plus OTOLoc)2025-08-01
K243482 — Self-Forming Magnet (Flexagon)2025-06-11
K243359 — MagDI System (MAG-02, DS-01)2025-02-28
K243213 — Self-Forming Magnet (FLEX SFM)2025-01-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.