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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 a medical device manufactured by Endosound, Inc.. It received FDA 510(k) clearance on 2025-10-17 under approval 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. It is manufactured by Endosound, Inc.. The 510(k) number is K250145.

When was Biopsy Port Adapter approved by the FDA?

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

What company makes Biopsy Port Adapter?

Biopsy Port Adapter is manufactured by Endosound, Inc..

What is the FDA product code for Biopsy Port Adapter?

The FDA product code for Biopsy Port Adapter is ODC.

Other Devices by Endosound, Inc.

K232518EndoSound Vision System; EVS

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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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