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FDA 510(k)

AXXENT VAGINAL APPLICATOR

K-Number: K072616 · 2008-05-09

ApplicantXoft, Inc.
Decision Date2008-05-09
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXXENT VAGINAL APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Xoft, Inc.. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K072616. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXXENT VAGINAL APPLICATOR?

AXXENT VAGINAL APPLICATOR is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Xoft, Inc.. The 510(k) number is K072616.

When did AXXENT VAGINAL APPLICATOR receive FDA 510(k) clearance?

AXXENT VAGINAL APPLICATOR received FDA 510(k) clearance on 2008-05-09, under 510(k) number K072616.

Who is the listed applicant for AXXENT VAGINAL APPLICATOR?

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 VAGINAL APPLICATOR?

The FDA product code for AXXENT VAGINAL APPLICATOR is JAD.

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, AB2067EK090417AXXENT FLEXISHIELD MINIK083734AXXENT SURFACE APPLICATOR, MODEL 710257K072683AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMK050843AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, 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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