FDA product code NZP: Sealant, Microbial
NZP is the FDA product code for sealant, microbial. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under NZP, 1 in the last five years, from 3 different applicants. The average 510(k) review took 252 days (median 234).
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.
Classification
| Field | Value |
|---|---|
| Device name | Sealant, Microbial |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for NZP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 220 |
| 2023 | 1 | 187 |
Compare with all 510(k) review times · Search every NZP clearance
Top NZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adhezion Biomedical, LLC | 2 | 2023-06-12 |
| Adhezion Biomedical | 1 | 2009-07-20 |
| Kimberly-Clark Corp. | 1 | 2006-09-29 |
Most recent NZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223669 | Adhezion Biomedical, LLC | SecurePortIV Advanced Catheter Securement Adhesive | 2023-06-12 | 187 |
| K170505 | Adhezion Biomedical, LLC | SecurePortIV Catheter Securement Adhesive | 2017-09-29 | 220 |
| K083354 | Adhezion Biomedical | FLORASEAL, MODEL FS350D | 2009-07-20 | 249 |
| K052870 | Kimberly-Clark Corp. | INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 | 2006-09-29 | 353 |
Recalls for NZP devices
openFDA lists no recalls for product code NZP.
Frequently asked questions
What is FDA product code NZP?
NZP is the FDA product code for sealant, microbial. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.
What device class is NZP?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code NZP?
Across 4 cleared submissions the average was 252 days from receipt to decision (median 234).
Which companies have the most NZP clearances?
Adhezion Biomedical, LLC (2); Adhezion Biomedical (1); Kimberly-Clark Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NZP
- Run a recall and safety report across every NZP manufacturer
- Watch product code NZP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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