Cleared Traditional

K052870 - INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052870 · Kimberly-Clark Corp. · General Hospital
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Sep 2006
Decision
353d
Days
Class 2
Risk

K052870 is an FDA 510(k) clearance for the INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200. Classified as Sealant, Microbial (product code NZP), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 29, 2006 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kimberly-Clark Corp. devices

Submission Details

510(k) Number K052870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date September 29, 2006
Days to Decision 353 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 128d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NZP Sealant, Microbial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.