K252933

DYNE PORT

510(k) number
K252933
Device name
DYNE PORT
Applicant
Dyne Medical Group, Inc. KR
Product code
ODC — Endoscope Channel Accessory
Decision date
2026-06-12
Date received
2025-09-15
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K252933.pdf

Official FDA record: K252933
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.