Cleared Abbreviated

FLORASEAL, MODEL FS350D (K083354) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K083354 · Adhezion Biomedical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
249d
Days
Class 2
Risk

K083354 is an FDA 510(k) clearance for the FLORASEAL, MODEL FS350D. Classified as Sealant, Microbial (product code NZP), Class II - Special Controls.

Submitted by Adhezion Biomedical (Hudson, US). The FDA issued a Cleared decision on July 20, 2009 after a review of 249 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Adhezion Biomedical devices

Submission Details

510(k) Number K083354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2008
Decision Date July 20, 2009
Days to Decision 249 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 129d · This submission: 249d
Pathway characteristics
Standards-based clearance path.

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.