Product code NZP

Device name: Sealant, Microbial
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.4370
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K223669	SecurePortIV Advanced Catheter Securement Adhesive	Adhezion Biomedical, LLC	2023-06-12
K170505	SecurePortIV Catheter Securement Adhesive	Adhezion Biomedical, LLC	2017-09-29
K083354	FLORASEAL, MODEL FS350D	Adhezion Biomedical	2009-07-20
K052870	INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200	Kimberly-Clark Corp.	2006-09-29

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05036912001595	INTEGUSEAL	ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED	2024-11-26
05036912001625	INTEGUSEAL	ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED	2024-11-26
M495FS035T1	FloraSeal Mini	ADHEZION BIOMEDICAL, LLC	2021-01-07
M495FS035T0	FloraSeal Mini	ADHEZION BIOMEDICAL, LLC	2021-01-07
00193494337360	AVANOS	Avanos Medical, Inc.	2020-07-16
00193494337377	AVANOS	Avanos Medical, Inc.	2020-07-16
20193494337364	AVANOS	Avanos Medical, Inc.	2020-07-16
10193494337374	AVANOS	Avanos Medical, Inc.	2020-07-16
M495SP015V502	SecurePortIV	ADHEZION BIOMEDICAL, LLC	2018-04-02
M495SP015V2	SecurePortIV	ADHEZION BIOMEDICAL, LLC	2018-02-05
M495SP015V1	SecurePortIV	ADHEZION BIOMEDICAL, LLC	2018-01-30
10680651337365	Halyard	Avanos Medical, Inc.	2017-03-15
10680651337372	Halyard	Avanos Medical, Inc.	2017-03-15
M495FS250D1	FloraSeal	ADHEZION BIOMEDICAL, LLC	2016-11-21

Related 510(k) Records#