Cleared Traditional

K130900 - EVICEL APPLICATION DEVICE

K130900 is an FDA 510(k) clearance for EVICEL APPLICATION DEVICE, manufactured by Ethicon Inc (On Behalf of Omrix Biopharaceuticals. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K130900 · Ethicon Inc (On Behalf of Omrix Biopharaceuticals · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
134d
Days
Class 2
Risk

K130900 is an FDA 510(k) clearance for the EVICEL APPLICATION DEVICE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Ethicon Inc (On Behalf of Omrix Biopharaceuticals (Somerville, US). The FDA issued a Cleared decision on August 13, 2013 after a review of 134 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 - K130900

510(k) Number K130900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2013
Decision Date August 13, 2013
Days to Decision 134 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 129d · This submission: 134d
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 621
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K130900.
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K130900 · EVICEL APPLICATION DEVICE
Download PDF FDA Summary Ethicon Inc (On Behal…