FDA.report

510(k) K150558

Device
Eclipse System
Applicant
Pelvalon, Inc.
510(k) number
K150558
Product code
PJH  
Decision
Substantially Equivalent (SESE)
Decision date
2015-11-12
Date received
2015-03-04
Regulation
876.5930
Classification name
Dynamic Rectal Control System
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
MILES ROSEN
Address
923 Thompson Pl. Sunnyvale CA US 94085 94085

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00815430020692EclipsePELVALON, INC.2018-09-11
00815430020708EclipsePELVALON, INC.2018-09-11
00815430020616EclipsePELVALON, INC.2018-09-11
00815430020623EclipsePELVALON, INC.2018-09-11
00815430020630EclipsePELVALON, INC.2018-09-11
00815430020647EclipsePELVALON, INC.2018-09-11
00815430020654EclipsePELVALON, INC.2018-09-11
00815430020661EclipsePELVALON, INC.2018-09-11
00815430020678EclipsePELVALON, INC.2018-09-11
00815430020685EclipsePELVALON, INC.2018-09-11
00815430020029EclipsePELVALON, INC.2016-09-23
00815430020296EclipsePELVALON, INC.2016-09-23
00815430020050EclipsePELVALON, INC.2016-09-23
00815430020067EclipsePELVALON, INC.2016-09-23
00815430020074EclipsePELVALON, INC.2016-09-23
00815430020043EclipsePELVALON, INC.2016-09-23
00815430020166EclipsePELVALON, INC.2016-09-23
00815430020173EclipsePELVALON, INC.2016-09-23
00815430020180EclipsePELVALON, INC.2016-09-23
00815430020197EclipsePELVALON, INC.2016-09-23
00815430020203EclipsePELVALON, INC.2016-09-23
00815430020210EclipsePELVALON, INC.2016-09-23
00815430020227EclipsePELVALON, INC.2016-09-23
00815430020234EclipsePELVALON, INC.2016-09-23
00815430020241EclipsePELVALON, INC.2016-09-23
00815430020258EclipsePELVALON, INC.2016-09-23
00815430020265EclipsePELVALON, INC.2016-09-23
00815430020272EclipsePELVALON, INC.2016-09-23
00815430020289EclipsePELVALON, INC.2016-09-23
00815430020005EclipsePELVALON, INC.2016-09-23

Other 510(k) Records For Product Code PJH  

510(k)DeviceApplicantDecision date
DEN140020ECLIPSE SYSTEMPelvalon2015-02-12

Legacy Summary

summary

FDA Review

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