LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT— 510(k) K081043

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K081043 for LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT, Substantially Equivalent on 2008-07-07. Applicant: Nxstage Medical, Inc..

Clearance details

Applicant: Nxstage Medical, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 2008-04-14
Decision date: 2008-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrence, MA, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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