TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set— 510(k) K201142

Substantially Equivalent

Simplivia Healthcare , Ltd.

FDA 510(k) clearance K201142 for TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set, Substantially Equivalent on 2021-02-25. Applicant: Simplivia Healthcare , Ltd..

Clearance details

Applicant: Simplivia Healthcare , Ltd.
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2020-04-29
Decision date: 2021-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kiryat Shmona, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code ONB

product code ONB

Malfunction: 3,615
Other: 13
Total: 3,628

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.