TNI Clear-Guard 3 angled breathing filter (1545020)— 510(k) K223258

Substantially Equivalent

Intersurgical , Ltd.

FDA 510(k) clearance K223258 for TNI Clear-Guard 3 angled breathing filter (1545020), Substantially Equivalent on 2023-06-15. Applicant: Intersurgical , Ltd..

Clearance details

Applicant: Intersurgical , Ltd.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2022-10-21
Decision date: 2023-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.