510(k) K252663— Inbentus Versatile

Substantially Equivalent

Iconic Solutions by Murcia, SL

Clearance details

Applicant: Iconic Solutions by Murcia, SL
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2025-08-22
Decision date: 2026-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murcia, ES

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.