DeviceClearance

Product code BSR— Anesthesiology

AUGUSTINE STYLET

Classification name
Stylet, Tracheal Tube
Device class
Class 1
Regulation
21 CFR 868.5790
Advisory panel
Anesthesiology
Total cleared
32
First cleared
Most recent

Market context for product code BSR

FDA has cleared 32 devices under product code BSR between 1977 and 2017, filed by 24 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code BSR

Adverse events under product code BSR

product code BSR
Death
2
Other
1
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code BSR

Data sourced from openFDA. This site is unofficial and independent of the FDA.