IRRIS (Infra-Red-Red Intubation System)— 510(k) K171411

Substantially Equivalent

A.R Guide IN Medical , Ltd.

FDA 510(k) clearance K171411 for IRRIS (Infra-Red-Red Intubation System), Substantially Equivalent on 2018-01-12. Applicant: A.R Guide IN Medical , Ltd..

Clearance details

Applicant: A.R Guide IN Medical , Ltd.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2017-05-15
Decision date: 2018-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.