DeviceClearance

Product code NAC— General, Plastic Surgery

ALGINATE FIBER

Classification name
Dressing, Wound, Hydrophilic
Device class
Class 1
Regulation
21 CFR 878.4018
Advisory panel
General, Plastic Surgery
Total cleared
4
First cleared
Most recent

Market context for product code NAC

FDA has cleared 4 devices under product code NAC between 1991 and 2008, filed by 4 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 NAC

Adverse events under product code NAC

product code NAC
Malfunction
475
Total
475

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 NAC

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