DeviceClearance

Self-Forming Magnet (Flexagon)— 510(k) K243482

Substantially Equivalent

GI Windows, Inc.

FDA 510(k) clearance K243482 for Self-Forming Magnet (Flexagon), Substantially Equivalent on 2025-06-11. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Westwood, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code SAH

view all

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