AUGUSTINE INTUBATION GUIDE(TM)— 510(k) K882659

Substantially Equivalent

Augustine Medical, Inc.

FDA 510(k) clearance K882659 for AUGUSTINE INTUBATION GUIDE(TM), Substantially Equivalent on 1988-07-21. Applicant: Augustine Medical, Inc..

Clearance details

Applicant: Augustine Medical, Inc.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1988-06-28
Decision date: 1988-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Springs, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.