Cleared Special

K090162 - EVICEL APPLICATION DEVICE

K090162 is an FDA 510(k) clearance for EVICEL APPLICATION DEVICE, manufactured by Omrix Biopharmaceuticals , Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 29-day FDA review.

K090162 · Omrix Biopharmaceuticals , Ltd. · General Hospital
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Feb 2009
Decision
29d
Days
Class 2
Risk

K090162 is an FDA 510(k) clearance for the EVICEL APPLICATION DEVICE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Omrix Biopharmaceuticals , Ltd. (Ramat Gan, IL). The FDA issued a Cleared decision on February 20, 2009 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omrix Biopharmaceuticals , Ltd. devices

FDA 510(k) Submission Details - K090162

510(k) Number K090162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2009
Decision Date February 20, 2009
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.

Regulatory Peers - FMF Syringe, Piston

All 379
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K090162.
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K072330 · Biomet, Inc. · Dec 2007