PRISMAFLEX SYSTEM, VERSION 3.20— 510(k) K072093

Substantially Equivalent

Gambro

FDA 510(k) clearance K072093 for PRISMAFLEX SYSTEM, VERSION 3.20, Substantially Equivalent on 2008-02-01. Applicant: Gambro.

Clearance details

Applicant: Gambro
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2007-07-30
Decision date: 2008-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.