THD Anopress
FDA 510(k) K161785 · Thd Spa
510(k) numberK161785
Submission
- Device name
- THD Anopress
- Applicant
- Thd Spa
Correggio, IT - Received
- June 29, 2016
- Decision date
- March 14, 2017
- 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
Other 510(k)s with product code KLA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K022023 | Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional | Clinical Innovations, Inc. | 01/07/2003SE |
More from Clinical Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K211623 | THD Procto Software SystemIYO · Special | 06/24/2021SE |
| K193512 | THD Procto Software SystemIYO · Traditional | 01/26/2020SE |
| K180135 | THD Anopress with THD SensyProbeKLA · Traditional | 03/08/2018SE |
| K141657 | THD RevolutionJAF · Traditional | 02/24/2015SE |
| K133687 | THD N-Ano AnoscopeFER · Special | 12/11/2013SE |
| K121135 | THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeFER · Traditional | 06/01/2012SE |
| K103647 | THD Disposable Anoscopes, Proctoscopes and RectoscopesFER · Special | 03/01/2011SE |
| K093497 | THD BandyFHN · Traditional | 07/15/2010SE |
| K091490 | Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesFER · Special | 06/11/2009SE |
| K090009 | THD Slide OneJAF · Special | 01/28/2009SE |
Questions and answers
When was THD Anopress cleared by the FDA?
THD Anopress (K161785) received a 510(k) decision of Substantially Equivalent on March 14, 2017, 258 days after the submission was received.
What is the product code of K161785?
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.