510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223669Substantially Equivalent

SecurePortIV Advanced Catheter Securement Adhesive

Adhezion Biomedical, LLC, Hudson NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223669 is the FDA 510(k) clearance record for SecurePortIV Advanced Catheter Securement Adhesive, a class II device, cleared for Adhezion Biomedical, LLC on under FDA product code NZP (Sealant, Microbial). FDA's definition for product code NZP reads: "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". FDA records list 12 510(k) clearances for Adhezion Biomedical, LLC, from to . As of , FDA records show no recalls naming K223669.

Clearance record

Decision date
Received
(187 days to decision)
Product code
NZP Sealant, Microbial
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Adhezion Biomedical, LLC 506 Pine Mountain Rd., Hudson NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZP

Trailing 12 months

FDA records hold no clearances under product code NZP in the trailing twelve months.

FDA records show no clearances under product code NZP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260