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)

AXXENT FLEXISHIELD MINI

K-Number: K090417 · 2009-06-23

ApplicantXoft, Inc.
Decision Date2009-06-23
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXXENT FLEXISHIELD MINI is the device name listed in this FDA 510(k) record. The listed applicant is Xoft, Inc.. It received FDA 510(k) clearance on 2009-06-23 under 510(k) number K090417. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXXENT FLEXISHIELD MINI?

AXXENT FLEXISHIELD MINI is a medical device that received FDA 510(k) clearance on 2009-06-23. The listed applicant is Xoft, Inc.. The 510(k) number is K090417.

When did AXXENT FLEXISHIELD MINI receive FDA 510(k) clearance?

AXXENT FLEXISHIELD MINI received FDA 510(k) clearance on 2009-06-23, under 510(k) number K090417.

Who is the listed applicant for AXXENT FLEXISHIELD MINI?

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

What is the FDA product code for AXXENT FLEXISHIELD MINI?

The FDA product code for AXXENT FLEXISHIELD MINI is IXI.

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 Xoft, 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.

K090914AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067EK083734AXXENT SURFACE APPLICATOR, MODEL 710257K072616AXXENT VAGINAL APPLICATORK072683AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMK050843AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

Related Devices (Code: IXI)

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.

K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLCK222639VHA Radiotherapy BolusVha DeanK214093VSP Bolus3D SystemsK132236.DECIMAL PROTON APERTURE.Decimal, Inc.K131150CURA COMPENSATORCura Medical Technologies, LLCK123893CURA COLLIMATORCura Medical Technologies, LLC

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.

↑