STYLET TRACHAEL TUBE— 510(k) K905133

Substantially Equivalent

Medical Devices, Inc.

FDA 510(k) clearance K905133 for STYLET TRACHAEL TUBE, Substantially Equivalent on 1991-04-22. Applicant: Medical Devices, Inc..

Clearance details

Applicant: Medical Devices, Inc.
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1990-11-15
Decision date: 1991-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSR

product code BSR

Death: 2
Other: 1
Total: 3

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.