DeviceClearance

Product code BSO— Anesthesiology

EPIDURAL CATHETER

Classification name
Catheter, Conduction, Anesthetic
Device class
Class 2
Regulation
21 CFR 868.5120
Advisory panel
Anesthesiology
Total cleared
75
First cleared
Most recent

Market context for product code BSO

FDA has cleared 75 devices under product code BSO between 1980 and 2025, filed by 49 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code BSO

Adverse events under product code BSO

product code BSO
Malfunction
688
Total
688

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 BSO

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