WAVES— 510(k) K111521

Substantially Equivalent

Waters Medical Systems, LLC

FDA 510(k) clearance K111521 for WAVES, Substantially Equivalent on 2012-02-16. Applicant: Waters Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Waters Medical Systems, LLC
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-01
Decision date: 2012-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K111521

K-number listed on FDA's recall record

Z-1013-2022 — WAVES WCM Kidney Cassette ModuleClass II·Terminated·Waters Medical Systems LLC·20220321

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111521.

Data sourced from openFDA. This site is unofficial and independent of the FDA.