Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set— 510(k) K212216

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K212216 for Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set, Substantially Equivalent on 2022-04-01. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2021-07-16
Decision date: 2022-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield Lake, IL, 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.