FDA.reportPublic FDA data

510(k) K223669

Device
SecurePortIV Advanced Catheter Securement Adhesive
Applicant
Adhezion Biomedical, LLC
510(k) number
K223669
Product code
NZP
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-12
Date received
2022-12-07
Regulation
878.4370
Classification name
Sealant, Microbial
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Richard Jones
Address
506 Pine Mountain Rd. Hudson NC US 28638 28638

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NZP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170505SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC2017-09-29
K083354FLORASEAL, MODEL FS350DAdhezion Biomedical2009-07-20
K052870INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200Kimberly-Clark Corp.2006-09-29