KLA — Monitor, Esophageal Motility, Anorectal Motility, And Tube Class II
FDA product code KLA covers "Monitor, Esophageal Motility, Anorectal Motility, And Tube", a Class II medical device regulated under 21 CFR 876.1725. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLA
- Device Class
- Class II
- Regulation Number
- 876.1725
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242666 | gi bionics | Fecobionics Anorectal System | February 12, 2025 |
| K242304 | neuraxis | RED | December 6, 2024 |
| K234107 | laborie medical technologies | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | April 23, 2024 |
| K180135 | thd | THD Anopress with THD SensyProbe | March 8, 2018 |
| K161785 | thd | THD ANOPRESS | March 14, 2017 |
| K143031 | medspira | mcompass Biofeedback Anorectal Manometry System | July 7, 2015 |
| K120088 | medspira | MCOMPASS ANORECTAL MANOMETRY SYSTEM | March 29, 2012 |
| K062362 | sarmed | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CA | April 13, 2007 |
| K031617 | mediplus | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER | January 16, 2004 |
| K032138 | medtronic vascular | MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANOREC | October 9, 2003 |
| K022023 | clinical innovations | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSUR | January 7, 2003 |
| K013704 | mediplus | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER | August 5, 2002 |
| K983665 | dentsleeve pty | MANOMETRIC ASSEMBLIES | May 17, 1999 |
| K964804 | oakfield instruments | FLEXILOG LS | August 6, 1997 |
| K964589 | oakfield instruments | FLEXILOG 3000 | March 4, 1997 |
| K961895 | oakfield instruments | FLEXILOG LS 13921 | November 4, 1996 |
| K961070 | synectics medical | ESOPHAGEAL MANOMETRY ANALYSIS MODULE | June 11, 1996 |
| K961056 | sandhill scientific | BIOVIEW MODEL S960000 | June 6, 1996 |
| K954798 | kay elemetrics | 7100 SWALLOWING WORKSTATION | June 4, 1996 |
| K941801 | sandhill scientific | ANALGRAPH | September 8, 1995 |