Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober
FDA 510(k) K011471 · Medtronic Functional Diagnostics A/S
510(k) numberK011471
Submission
- Device name
- Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober
- Applicant
- Medtronic Functional Diagnostics A/S
Skovlunde, DK - Received
- May 14, 2001
- Decision date
- November 8, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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| K201106 | IntraMarX 3D Radiopaque MarkerFFX · Special | Anx Robotica Corp | 05/21/2020SE |
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| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeFFX · Traditional | Diversatek Healthcare | 10/03/2019SE |
| K181760 | Transit-PelletsFFX · Traditional | Medifactia AB | 08/08/2019SE |
| K183072 | EndoFLIP SystemFFX · Traditional | Crospon, Ltd. | 02/15/2019SE |
More from Crospon, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id…MYE · Traditional | 11/21/2002SE |
| K002992 | Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,901…IKT · Traditional | 08/15/2001SE |
| K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry…FFX · Traditional | 08/10/2001SE |
| K010130 | Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103FFX · Special | 02/07/2001SE |
| K000386 | Polygram 98 Anorectal Function Testing Application, Model 9043S0111FFX · Traditional | 05/05/2000SE |
| K992715 | Neuro Urodynamic Suite, Model 9032E0101FEN · Traditional | 02/28/2000SE |
| K992713 | Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models…FFX · Traditional | 11/10/1999SE |
| K991389 | Anorectal Manometry Suite, Model 9032S0201FFX · Traditional | 07/15/1999SE |
| K990375 | Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75IKT · Special | 03/09/1999SE |
| K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111FFX · Traditional | 02/04/1999SE |
Questions and answers
When was Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober cleared by the FDA?
Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober (K011471) received a 510(k) decision of Substantially Equivalent on November 8, 2002, 543 days after the submission was received.
What is the product code of K011471?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.