Cleared Traditional

K070575 - EVICEL APPLICATION DEVICE

K070575 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 Traditional 510(k) pathway after a 90-day FDA review.

K070575 · Omrix Biopharmaceuticals , Ltd. · General Hospital
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May 2007
Decision
90d
Days
Class 2
Risk

K070575 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 May 29, 2007 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K070575

510(k) Number K070575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2007
Decision Date May 29, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 638
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K070575.
GENIE, MODEL CH-200
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HASELMEIER PEN
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K063348 · Daejin Tech Medical Manufacturing Co., Ltd. · Mar 2007
K070575 · EVICEL APPLICATION DEVICE
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