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FDA 510(k)

Biopsy Port Adapter

K-Number: K250145 · 2025-10-17

ApplicantEndosound, Inc.
Decision Date2025-10-17
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Biopsy Port Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Endosound, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K250145. 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 Biopsy Port Adapter?

Biopsy Port Adapter is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Endosound, Inc.. The 510(k) number is K250145.

When did Biopsy Port Adapter receive FDA 510(k) clearance?

Biopsy Port Adapter received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250145.

Who is the listed applicant for Biopsy Port Adapter?

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

What is the FDA product code for Biopsy Port Adapter?

The FDA product code for Biopsy Port Adapter is ODC.

Other records listing Endosound, 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.

K232518EndoSound Vision System; EVS

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.

K252933DYNE PORTDyne Medical Group, 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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