PC Polygraf
FDA 510(k) K872712 · Synectics-Dantec
510(k) numberK872712
Submission
- Device name
- PC Polygraf
- Applicant
- Synectics-Dantec
Irving, TX, US - Received
- July 10, 1987
- Decision date
- March 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K242666 | Fecobionics Anorectal SystemKLA · Traditional | Gi Bionics, LLC | 02/12/2025SE |
| K242304 | RedKLA · Traditional | Neuraxis, Inc. | 12/06/2024SE |
| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)KLA · Traditional | Laborie Medical Technologies, Corp. | 04/23/2024SE |
| K180135 | THD Anopress with THD SensyProbeKLA · Traditional | Thd Spa | 03/08/2018SE |
| K161785 | THD AnopressKLA · Traditional | Thd Spa | 03/14/2017SE |
| K143031 | mcompass Biofeedback Anorectal Manometry SystemKLA · Traditional | Medspira, LLC | 07/07/2015SE |
| K120088 | Mcompass Anorectal Manometry SystemKLA · Traditional | Medspira, LLC | 03/29/2012SE |
| K062362 | Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry CathetersKLA · Traditional | Sarmed Srl | 04/13/2007SE |
| K031617 | Mediplus Single Use Lower Gi Manometry CatheterKLA · Traditional | Mediplus , Ltd. | 01/16/2004SE |
| K032138 | Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal…KLA · Traditional | Medtronic Vascular | 10/09/2003SE |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K961346 | PH Analysis ModuleFFT · Traditional | 01/29/1997SE |
| K925405 | Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional | 09/30/1994SE |
| K924875 | Microtrapper/Microdigitrapper, Add ModificationsBZQ · Traditional | 06/30/1994ST |
| K914793 | Monocrystant Ph/Les Catheter, ModificationKLA · Traditional | 12/13/1993SE |
| K924383 | Synectics Liberty System, PC Polygraf/Polygram UroFAP · Traditional | 06/18/1993SE |
| K913817 | Monocrystant Ph-Reference Catheter, ModificationFFT · Traditional | 06/11/1992SE |
| K914624 | PH Meter, ModificationFFT · Traditional | 04/28/1992SE |
| K914219 | Airway ThermistorBZG · Traditional | 02/26/1992SE |
| K913387 | Digitrapper Mark IIIFFT · Traditional | 12/27/1991SE |
| K904625 | Synectics Liberty System, PC Polygraf and PolygramBZG · Traditional | 08/20/1991SE |
Questions and answers
When was PC Polygraf cleared by the FDA?
PC Polygraf (K872712) received a 510(k) decision of Substantially Equivalent on March 18, 1988, 252 days after the submission was received.
What is the product code of K872712?
The FDA product code is KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube, a Class II (moderate risk) device regulated under 21 CFR 876.1725.