URO PRO— 510(k) K042457

Substantially Equivalent

W.O.M. World of Medicine AG

FDA 510(k) clearance K042457 for URO PRO, Substantially Equivalent on 2004-10-25. Applicant: W.O.M. World of Medicine AG. Device class: 2.

Clearance details

Applicant: W.O.M. World of Medicine AG
Product code: Code LJH
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2004-09-10
Decision date: 2004-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hingham, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K042457

K-number listed on FDA's recall record

Z-2080-2014 — Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.Class II·Terminated·Stryker Endoscopy·20140620

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042457.

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