FDA.report

510(k) K003580

Device
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
Applicant
UNISENSOR AG
510(k) number
K003580
Product code
FFX  
Decision
Substantially Equivalent (SESE)
Decision date
2001-07-31
Date received
2000-11-20
Regulation
876.1725
Classification name
System, Gastrointestinal Motility (electrical)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
ROBERT N CLARK
Address
13605 W. 7th Ave. Golden CO US 80401 80401

FDA Registration Numbers

Source Documents

510(k) summary PDF

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07640172971840UniTip CatheterUnisensor AG2016-09-19
07640172971857UniTip CatheterUnisensor AG2016-09-19
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07640172971888UniTip CatheterUnisensor AG2016-09-19
07640172971895UniTip CatheterUnisensor AG2016-09-19
07640172971901UniTip CatheterUnisensor AG2016-09-19
07640172971918UniTip CatheterUnisensor AG2016-09-19
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Other 510(k) Records For Product Code FFX  

510(k)DeviceApplicantDecision date
K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC2025-12-05
K240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.2024-05-06
K231861EndoflipTM 300 SystemCovidien, LLC2023-07-21
K223705EndoflipTM 300Covidien, LLC2023-04-14
K222000Transit-PelletsMedifactia AB2023-01-18
K201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp2020-05-21
K191087IntraMarX Radiopaque MarkersAnx Robotica Corp2019-12-18
K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeDiversatek Healthcare2019-10-03
K181760Transit-PelletsMedifactia AB2019-08-08
K183072EndoFLIP SystemCrospon, Ltd.2019-02-15
K181750SITZMARKSKonsyl Pharmaceuticals2018-11-15
K170833EndoFLIP® System with FLIP Topography moduleCrospon, Ltd.2017-04-17
K160287Rapid Barostat Bag (RBB) Pump and CatheterMui Scientific2017-03-14
K160170Lehman Manometry CatheterWilson-Cook Medical, Inc.2016-06-20
K160725EndoFLIPCrospon, Ltd.2016-05-01

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FDA Review

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