NZP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sealant, Microbial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Medical specialty
- General, Plastic Surgery
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SecurePortIV Advanced Catheter Securement Adhesive (K223669) | Adhezion Biomedical, LLC | 2023-06-12 |
| SecurePortIV Catheter Securement Adhesive (K170505) | Adhezion Biomedical, LLC | 2017-09-29 |
| FLORASEAL, MODEL FS350D (K083354) | Adhezion Biomedical | 2009-07-20 |
| INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 (K052870) | Kimberly-Clark Corp. | 2006-09-29 |
Track NZP automatically
Every clearance here is in the API, with alerts when new ones post.