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FDA 510(k)

DYNE PORT

K-Number: K252933 · 2026-06-12

ApplicantDyne Medical Group, Inc.
Decision Date2026-06-12
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DYNE PORT is the device name listed in this FDA 510(k) record. The listed applicant is Dyne Medical Group, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252933. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNE PORT?

DYNE PORT is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Dyne Medical Group, Inc.. The 510(k) number is K252933.

When did DYNE PORT receive FDA 510(k) clearance?

DYNE PORT received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252933.

Who is the listed applicant for DYNE PORT?

The FDA 510(k) record lists Dyne Medical Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNE PORT?

The FDA product code for DYNE PORT is ODC.

Other records listing Dyne Medical Group, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240203URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)

Related Devices (Code: ODC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems CorporationK250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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