Sealant, Microbial

NZP · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4370

Classification

FDA Product Code: NZP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4370
Review panel: HO
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 9

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown