K223669 is an FDA 510(k) clearance for the SecurePortIV Advanced Catheter Securement Adhesive. This device is classified as a Sealant, Microbial (Class II - Special Controls, product code NZP).
Submitted by Adhezion Biomedical, LLC (Hudson, US). The FDA issued a Cleared decision on June 12, 2023, 187 days after receiving the submission on December 7, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370. 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..
| 510(k) Number | K223669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2022 |
| Decision Date | June 12, 2023 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NZP - Sealant, Microbial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |
| 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. |