Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACUFEX ENDOFIX BUTTON

K-Number: K922559 · 1992-12-24

ApplicantAcufex Microsurgical, Inc.
Decision Date1992-12-24
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACUFEX ENDOFIX BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K922559. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX ENDOFIX BUTTON?

ACUFEX ENDOFIX BUTTON is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K922559.

When did ACUFEX ENDOFIX BUTTON receive FDA 510(k) clearance?

ACUFEX ENDOFIX BUTTON received FDA 510(k) clearance on 1992-12-24, under 510(k) number K922559.

Who is the listed applicant for ACUFEX ENDOFIX BUTTON?

The FDA 510(k) record lists Acufex Microsurgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUFEX ENDOFIX BUTTON?

The FDA product code for ACUFEX ENDOFIX BUTTON is EBG.

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 Acufex Microsurgical, Inc. 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

View all 78 devices →

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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.

↑