510(k) K223669
K223669 is an FDA 510(k) premarket notification submitted by Adhezion Biomedical, LLC for the device "SecurePortIV Advanced Catheter Securement Adhesive". The FDA issued a decision of Substantially Equivalent on June 12, 2023. The device falls under product code NZP (Sealant, Microbial), a Class II device regulated under 21 CFR 878.4370. Adhezion Biomedical, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2023
- Date Received
- December 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Microbial
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type
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.