Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets— 510(k) K211911

Unknown

Coloplast Corp.

FDA 510(k) clearance K211911 for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets, Unknown on 2022-03-10. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code LJE
Advisory panel: Unknown
Date received: 2021-06-21
Decision date: 2022-03-10
Decision: Unknown
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

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.