Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
FDA 510(k) K234107 · Laborie Medical Technologies, Corp.
510(k) numberK234107
Submission
- Device name
- Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
- Applicant
- Laborie Medical Technologies, Corp.
Portsmouth, NH, US - Received
- December 26, 2023
- Decision date
- April 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
| K022023 | Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional | Clinical Innovations, Inc. | 01/07/2003SE |
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| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK · Special | 08/27/2024SE |
| K240007 | Solar Compact (G4-1)FFX · Traditional | 05/06/2024SE |
| K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipFBK · Traditional | 07/21/2009SE |
| K082614 | Evox Electro Diagnostic DeviceGWF · Traditional | 03/06/2009SE |
| K081781 | NuwavIYO · Traditional | 07/09/2008SE |
| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | 03/05/2008SE |
| K070331 | Urostym Biofeedback and Stimulation Device and AccessoriesKPI · Traditional | 05/04/2007SE |
| K962009 | UrostymKPI · Traditional | 05/20/1997SE |
| K955856 | Tex-Aid BlueLKY · Traditional | 02/16/1996SE |
| K955810 | U-TexFHA · Traditional | 01/24/1996SE |
Questions and answers
When was Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) cleared by the FDA?
Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (K234107) received a 510(k) decision of Substantially Equivalent on April 23, 2024, 119 days after the submission was received.
What is the product code of K234107?
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.