FDA 510(k)

MODIFICATION TO SOLAR GI

K-Number: K071094 · 2007-08-13

ApplicantMedical Measurement Systems B.V.

Decision Date2007-08-13

Product CodeFFX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SOLAR GI is the device name listed in this FDA 510(k) record. The listed applicant is Medical Measurement Systems B.V.. It received FDA 510(k) clearance on 2007-08-13 under 510(k) number K071094. 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 MODIFICATION TO SOLAR GI?

MODIFICATION TO SOLAR GI is a medical device that received FDA 510(k) clearance on 2007-08-13. The listed applicant is Medical Measurement Systems B.V.. The 510(k) number is K071094.

When did MODIFICATION TO SOLAR GI receive FDA 510(k) clearance?

MODIFICATION TO SOLAR GI received FDA 510(k) clearance on 2007-08-13, under 510(k) number K071094.

Who is the listed applicant for MODIFICATION TO SOLAR GI?

The FDA 510(k) record lists Medical Measurement Systems B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO SOLAR GI?

The FDA product code for MODIFICATION TO SOLAR GI 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Measurement Systems B.V. as applicant

K121014SOLAR GI K060166OHMEGA K052338SOLAR GI K050993MMS VIDEO OPTION K031084SOLAR GI SYSTEM K031930HIGH SPEED EMG MODULE

View all 7 devices →

Related Devices (Code: FFX)

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC K240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLC K223705EndoflipTM 300Covidien, LLC K222000Transit-PelletsMedifactia AB K201106IntraMarX 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.