FDA.report

510(k) K062222

Device
UNITIP HIGH RESOLUTION CATHETER
Applicant
UNISENSOR AG
510(k) number
K062222
Product code
FFX  
Decision
Substantially Equivalent (SESE)
Decision date
2007-03-15
Date received
2006-08-02
Regulation
876.1725
Classification name
System, Gastrointestinal Motility (electrical)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
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

Related GUDID Devices

Primary DIBrandCompanyPublished
07640172974032UniTip High Resolution CatheterUnisensor AG2022-11-03
07640172974025UniTip High Resolution CatheterUnisensor AG2022-11-03
07640172974018UniTip High Resolution CatheterUnisensor AG2022-04-20
07640172973936UniTip High Resolution CatheterUnisensor AG2022-01-19
07640172973998UniTip High Resolution CatheterUnisensor AG2022-01-13
07640172974001UniTip High Resolution CatheterUnisensor AG2021-10-20
07640172973905UniTip High Resolution CatheterUnisensor AG2021-02-04
07640172973882UniTip High Resolution CatheterUnisensor AG2021-02-04
07640172973899UniTip High Resolution CatheterUnisensor AG2021-02-04
07640172973851UniTip High Resolution CatheterUnisensor AG2020-12-07
07640172973837UniTip High Resolution CatheterUnisensor AG2020-10-09
07640172973813UniTip High Resolution CatheterUnisensor AG2019-11-11
07640172973806UniTip High Resolution CatheterUnisensor AG2019-06-17
07640172973738UniTip High Resolution CatheterUnisensor AG2019-02-04
07640172973714UniTip High Resolution CatheterUnisensor AG2019-01-07
07640172973707UniTip High Resolution CatheterUnisensor AG2018-12-03
07640172973691UniTip High Resolution CatheterUnisensor AG2018-11-19
07640172973677UniTip High Resolution CatheterUnisensor AG2018-10-22
07640172973653UniTip High Resolution CatheterUnisensor AG2018-09-17
07640172973660UniTip High Resolution CatheterUnisensor AG2018-09-17
07640172973646UniTip High Resolution CatheterUnisensor AG2018-07-23
07640172973622UniTip High Resolution CatheterUnisensor AG2018-05-21
07640172973615UniTip High Resolution CatheterUnisensor AG2018-05-07
07640172973608UniTip High Resolution CatheterUnisensor AG2018-04-23
07640172973578UniTip High Resolution CatheterUnisensor AG2018-02-12
07640172973561UniTip High Resolution CatheterUnisensor AG2018-01-29
07640172973554UniTip High Resolution CatheterUnisensor AG2018-01-22
07640172973530UniTip High Resolution CatheterUnisensor AG2017-12-11
07640172973516UniTip High Resolution CatheterUnisensor AG2017-11-20
07640172973509UniTip High Resolution CatheterUnisensor AG2017-11-20

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

Legacy Summary

summary

FDA Review

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