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FDA 510(k)

ACCELL EVO3 (FORMERLY ACCELL A2I)

K-Number: K103742 · 2011-03-17

ApplicantIntegra Life Sciences
Decision Date2011-03-17
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCELL EVO3 (FORMERLY ACCELL A2I) is the device name listed in this FDA 510(k) record. The listed applicant is Integra Life Sciences. It received FDA 510(k) clearance on 2011-03-17 under 510(k) number K103742. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCELL EVO3 (FORMERLY ACCELL A2I)?

ACCELL EVO3 (FORMERLY ACCELL A2I) is a medical device that received FDA 510(k) clearance on 2011-03-17. The listed applicant is Integra Life Sciences. The 510(k) number is K103742.

When did ACCELL EVO3 (FORMERLY ACCELL A2I) receive FDA 510(k) clearance?

ACCELL EVO3 (FORMERLY ACCELL A2I) received FDA 510(k) clearance on 2011-03-17, under 510(k) number K103742.

Who is the listed applicant for ACCELL EVO3 (FORMERLY ACCELL A2I)?

The FDA 510(k) record lists Integra Life Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCELL EVO3 (FORMERLY ACCELL A2I)?

The FDA product code for ACCELL EVO3 (FORMERLY ACCELL A2I) is MBP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Integra Life Sciences as applicant

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.

K120600DURAGEN SECURE DURAL REGNERATION MATRIXK103248INTEGRITY SPINAL CARE SYSTEM

Related Devices (Code: MBP)

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.

K242799PliaFX FloLifenet HealthK130703VIVORTE BVFVivorte, Inc.K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.K122513CLEARED UNDER GRAFTON II EDBMMedtronic Sofamor Danek, Inc.K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHans Biomed Corp.K091193ACCELL EVO3CIsotis Orthobiologics, Inc.

Official Source

View on FDA Database →

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

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