FDA Product Code NZP: Sealant, Microbial
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.
Leading manufacturers include Adhezion Biomedical, LLC, Kimberly-Clark Corp. and Adhezion Biomedical.
4
Total
4
Cleared
252d
Avg days
2006
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Sealant, Microbial Devices (Product Code NZP)
4 devices
Cleared
Jun 12, 2023
SecurePortIV Advanced Catheter Securement Adhesive
Adhezion Biomedical, LLC
General Hospital
187d
Cleared
Sep 29, 2017
SecurePortIV Catheter Securement Adhesive
Adhezion Biomedical, LLC
General Hospital
220d
Cleared
Jul 20, 2009
FLORASEAL, MODEL FS350D
Adhezion Biomedical
General Hospital
249d
Cleared
Sep 29, 2006
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
Kimberly-Clark Corp.
General Hospital
353d
About Product Code NZP - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code NZP since 2006, with 4 receiving FDA clearance (average review time: 252 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.