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Biopsy Port Adapter

by Endosound, Inc.

510(k) K250145

Biopsy Port Adapter is a medical device (FDA Class II; FDA product code ODC, Endoscope Channel Accessory) made by Endosound, Inc., cleared under FDA 510(k) K250145 on 17 Oct 2025, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250145 Date17 Oct 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ODC
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K250145

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250145
UDI-DISize and differences
EndoSound® Biopsy Port Adapter (5 pack) 5064
Endosound, Inc.
5064 / 506400850050934202 —On the market
EndoSound® Biopsy Port Adapter 5054
Endosound, Inc.
5054 / 505400850050934196 —On the market

Similar devices

Other devices filed under FDA product code ODC (Endoscope Channel Accessory).

Other devices from Endosound, Inc.

See all devices from Endosound, Inc. →