NZP — Sealant, Microbial Class II
Classification Details
- Product Code
- NZP
- Device Class
- Class II
- Regulation Number
- 878.4370
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223669 | adhezion biomedical | SecurePortIV Advanced Catheter Securement Adhesive | June 12, 2023 |
| K170505 | adhezion biomedical | SecurePortIV Catheter Securement Adhesive | September 29, 2017 |
| K083354 | adhezion biomedical | FLORASEAL, MODEL FS350D | July 20, 2009 |
| K052870 | kimberly-clark | INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 | September 29, 2006 |