510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NZPClass II

Sealant, Microbial

21 CFR 878.4370 / General, Plastic Surgery
FDA source (opens on fda.gov)

NZP is the FDA product code for Sealant, Microbial, a class II device type, regulated under 21 CFR 878.4370. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NZP
Device name
Sealant, Microbial
FDA 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.
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code NZP

By decision year
4 clearances under product code NZP with a decision year between 2006 and 2023, 2006 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NZP by decision year
YearClearances
20061
20091
20171
20231

Applicants with the most clearances

Product code NZP
Applicants holding the most 510(k) clearances under product code NZP
ApplicantClearances
Adhezion Biomedical, LLC3
Kimberly-Clark Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code