Xenium Xph, Models 110, 130, 150, 170, 190 and 210

by Baxter Healthcare Corporation 510(k)

Active United States

510(k) K083778

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK083778	Date20 Feb 2009Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

510(k)

510(k) Number: K083778
FDA Product Code: KDI
Models / Variants: 110
130
150
170
190
210

Device Class: Class II
Regulation: 21 CFR Part 876.5860
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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