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

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..

Clearance details

Applicant: GI Windows, Inc.
Product code: Code SAH
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

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