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 Kimberly-Clark Corp. and Adhezion Biomedical, LLC.
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, 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.