DeviceClearance

Product code BWN— General, Plastic Surgery

AIRFRAME SURGICAL DRAPE SUPPORT

Classification name
Table And Attachments, Operating-Room
Device class
Class 1
Regulation
21 CFR 878.4950
Advisory panel
General, Plastic Surgery
Total cleared
20
First cleared
Most recent

Market context for product code BWN

FDA has cleared 20 devices under product code BWN between 1979 and 1994, filed by 19 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 BWN

Adverse events under product code BWN

product code BWN
Other
1
Total
1

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 BWN

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