DYNE PORT— 510(k) K252933

Substantially Equivalent

Dyne Medical Group, Inc.

FDA 510(k) clearance K252933 for DYNE PORT, Substantially Equivalent on 2026-06-12. Applicant: Dyne Medical Group, Inc.. Device class: 2.

Clearance details

Applicant: Dyne Medical Group, Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-15
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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