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)

BAROSTAT SOFTWARE OPTION

K-Number: K120997 · 2012-08-27

ApplicantCrospon, Ltd.
Decision Date2012-08-27
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAROSTAT SOFTWARE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Crospon, Ltd.. It received FDA 510(k) clearance on 2012-08-27 under 510(k) number K120997. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAROSTAT SOFTWARE OPTION?

BAROSTAT SOFTWARE OPTION is a medical device that received FDA 510(k) clearance on 2012-08-27. The listed applicant is Crospon, Ltd.. The 510(k) number is K120997.

When did BAROSTAT SOFTWARE OPTION receive FDA 510(k) clearance?

BAROSTAT SOFTWARE OPTION received FDA 510(k) clearance on 2012-08-27, under 510(k) number K120997.

Who is the listed applicant for BAROSTAT SOFTWARE OPTION?

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

What is the FDA product code for BAROSTAT SOFTWARE OPTION?

The FDA product code for BAROSTAT SOFTWARE OPTION is FFX.

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 Crospon, Ltd. 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.

K183072EndoFLIP SystemK172128EsoFLIP® ES-310 Balloon CatheterK170833EndoFLIP® System with FLIP Topography moduleK160725EndoFLIPK132337ESOFLIP BALLOON DILATION CATHETERK130906ENDOFLIP CATHETER

View all 11 devices →

Related Devices (Code: FFX)

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.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp

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.

↑