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FDA 510(k)

EVICEL APPLICATION DEVICE

K-Number: K130900 · 2013-08-13

ApplicantEthicon Inc (On Behalf of Omrix Biopharaceuticals
Decision Date2013-08-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EVICEL APPLICATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Inc (On Behalf of Omrix Biopharaceuticals. It received FDA 510(k) clearance on 2013-08-13 under 510(k) number K130900. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVICEL APPLICATION DEVICE?

EVICEL APPLICATION DEVICE is a medical device that received FDA 510(k) clearance on 2013-08-13. The listed applicant is Ethicon Inc (On Behalf of Omrix Biopharaceuticals. The 510(k) number is K130900.

When did EVICEL APPLICATION DEVICE receive FDA 510(k) clearance?

EVICEL APPLICATION DEVICE received FDA 510(k) clearance on 2013-08-13, under 510(k) number K130900.

Who is the listed applicant for EVICEL APPLICATION DEVICE?

The FDA 510(k) record lists Ethicon Inc (On Behalf of Omrix Biopharaceuticals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVICEL APPLICATION DEVICE?

The FDA product code for EVICEL APPLICATION DEVICE is FMF.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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