Solar Gi

FDA 510(k) K052338 · Medical Measurement Systems B.V.

Substantially Equivalent

510(k) numberK052338

Submission

Device name
Solar Gi
Applicant
Medical Measurement Systems B.V.
Enschede Overijssel, NL
Received
August 26, 2005
Decision date
December 15, 2005
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FFX – System, Gastrointestinal Motility (Electrical)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1725
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FFX

510(k)DeviceApplicantDecision
K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)FFX · Traditional Medspira, LLC12/05/2025SE
K240007Solar Compact (G4-1)FFX · Traditional Laborie Medical Technologies, Corp.05/06/2024SE
K231861EndoflipTM 300 SystemFFX · Special Covidien, LLC07/21/2023SE
K223705EndoflipTM 300FFX · Traditional Covidien, LLC04/14/2023SE
K222000Transit-PelletsFFX · Traditional Medifactia AB01/18/2023SE
K201106IntraMarX 3D Radiopaque MarkerFFX · Special Anx Robotica Corp05/21/2020SE
K191087IntraMarX Radiopaque MarkersFFX · Traditional Anx Robotica Corp12/18/2019SE
K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeFFX · Traditional Diversatek Healthcare10/03/2019SE
K181760Transit-PelletsFFX · Traditional Medifactia AB08/08/2019SE
K183072EndoFLIP SystemFFX · Traditional Crospon, Ltd.02/15/2019SE

More from Crospon, Ltd.

510(k)DeviceDecision
K121014Solar GiFFX · Traditional 08/01/2012SE
K071094Modification to Solar GiFFX · Traditional 08/13/2007SE
K060166OhmegaFFX · Traditional 04/21/2006SE
K050993MMS Video OptionLLZ · Traditional 05/26/2005SE
K031084Solar Gi SystemFFX · Traditional 03/19/2004SE
K031930High Speed Emg ModuleGWF · Traditional 03/03/2004SE

Questions and answers

When was Solar Gi cleared by the FDA?

Solar Gi (K052338) received a 510(k) decision of Substantially Equivalent on December 15, 2005, 111 days after the submission was received.

What is the product code of K052338?

The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.