DeviceClearance

Product code NZP— General, Plastic Surgery

FLORASEAL, MODEL FS350D

Classification name
Sealant, Microbial
Device class
Class 2
Regulation
21 CFR 878.4370
Advisory panel
General, Plastic Surgery
Total cleared
4
First cleared
Most recent

FDA classification definition

“Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.”

— U.S. Food and Drug Administration, device classification record for product code NZP under 21 CFR 878.4370, via openFDA

Market context for product code NZP

FDA has cleared 4 devices under product code NZP between 2006 and 2023, filed by 3 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

Top applicants under product code NZP

Recent clearances under product code NZP

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