DYNE PORT— 510(k) K252933

Name: FDA 510(k) clearance K252933
Creator: U.S. Food and Drug Administration
Published: 2026-06-12

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.

Summary

DYNE PORT from Dyne Medical Group is filed under ODC, endoscope channel accessories. The record doesn't describe the product beyond its name and the code name.

Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Dyne Medical filed from Gyeonggi-Do, South Korea. Review took 270 calendar days (September 15, 2025 to June 12, 2026).

Clearance details

Applicant: Dyne Medical Group, Inc.
Product code: Product 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.