SURFLO Hybria Closed System Safety IV Catheter— 510(k) K252398

Substantially Equivalent

Terumo Medical Products (Hangzhou) Co., Ltd.

FDA 510(k) clearance K252398 for SURFLO Hybria Closed System Safety IV Catheter, Substantially Equivalent on 2025-12-17. Applicant: Terumo Medical Products (Hangzhou) Co., Ltd..

Clearance details

Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2025-07-31
Decision date: 2025-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.