ULTRACONCENTRATOR SYSTEM— 510(k) K011148

Substantially Equivalent

Interpore Cross Intl.

FDA 510(k) clearance K011148 for ULTRACONCENTRATOR SYSTEM, Substantially Equivalent on 2001-06-13. Applicant: Interpore Cross Intl..

Clearance details

Applicant: Interpore Cross Intl.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-16
Decision date: 2001-06-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.