510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K052870Substantially Equivalent

Integuseal Microbial Sealant, Model Is 100 and 1S200

Kimberly-Clark Corporation, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052870 is the FDA 510(k) clearance record for INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200, a class II device, cleared for Kimberly-Clark Corp. 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 122 510(k) clearances for Kimberly-Clark Corp., from to . As of , FDA records show no recalls naming K052870.

Clearance record

Decision date
Received
(353 days to decision)
Product code
NZP Sealant, Microbial
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kimberly-Clark Corp. 5353 Wayzata Blvd. Suite 505, Minneapolis MN
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