Panels › Gastroenterology, Urology › Product code KLA · Class 2
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Regulation 876.1725
0510(k)s in 12 months (31 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in KLA
| Company | 510(k)s | Recalls |
|---|---|---|
| Oakfield Instruments, Ltd. | 3 | 0 |
| Mediplus , Ltd. | 2 | 0 |
| Medspira, LLC | 2 | 0 |
| Physio-Control Corp. | 2 | 0 |
| Sandhill Scientific, Inc. | 2 | 0 |
| Synectics-Dantec | 2 | 0 |
| Thd Spa | 2 | 0 |
| Wilson-Cook Medical, Inc. | 2 | 0 |
| Clinical Innovations, Inc. | 1 | 0 |
| Dentsleeve Pty., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2025 | K242666 | Fecobionics Anorectal System Gi Bionics, LLC | KLA |
| Dec 6, 2024 | K242304 | RED Neuraxis, Inc. | KLA |
| Apr 23, 2024 | K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) Laborie Medical Technologies, Corp. | KLA |
| Mar 8, 2018 | K180135 | THD Anopress with THD SensyProbe Thd Spa, IT | KLA |
| Mar 14, 2017 | K161785 | THD ANOPRESS Thd Spa, IT | KLA |
| Jul 7, 2015 | K143031 | mcompass Biofeedback Anorectal Manometry System Medspira, LLC | KLA |
| Mar 29, 2012 | K120088 | MCOMPASS ANORECTAL MANOMETRY SYSTEM Medspira, LLC | KLA |
| Apr 13, 2007 | K062362 | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS Sarmed Srl, IT | KLA |
| Jan 16, 2004 | K031617 | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER Mediplus , Ltd. | KLA |
| Oct 9, 2003 | K032138 | MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER Medtronic Vascular | KLA |
| Jan 7, 2003 | K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 Clinical Innovations, Inc. | KLA |
| Aug 5, 2002 | K013704 | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER Mediplus , Ltd. | KLA |
| May 17, 1999 | K983665 | MANOMETRIC ASSEMBLIES Dentsleeve Pty., Ltd., AU | KLA |
| Aug 6, 1997 | K964804 | FLEXILOG LS Oakfield Instruments, Ltd., GB | KLA |
| Mar 4, 1997 | K964589 | FLEXILOG 3000 Oakfield Instruments, Ltd., GB | KLA |
| Nov 4, 1996 | K961895 | FLEXILOG LS 13921 Oakfield Instruments, Ltd., GB | KLA |
| Jun 11, 1996 | K961070 | ESOPHAGEAL MANOMETRY ANALYSIS MODULE Synectics Medical, Inc. | KLA |
| Jun 6, 1996 | K961056 | BIOVIEW MODEL S960000 Sandhill Scientific, Inc. | KLA |
| Jun 4, 1996 | K954798 | 7100 SWALLOWING WORKSTATION Kay Elemetrics Corp. | KLA |
| Sep 8, 1995 | K941801 | ANALGRAPH Sandhill Scientific, Inc. | KLA |
| Aug 23, 1994 | K922553 | CLA-COMPUTERIZED LARYNGEAL ANALYZER H.I.L. Research, Ltd. | KLA |
| Dec 13, 1993 | K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION Synectics-Dantec, SE | KLA |
| Jan 25, 1991 | K901125 | PROVOCATIVE SENSITIVITY BALLOON Wilson-Cook Medical, Inc. | KLA |
| Jul 16, 1990 | K900239 | WILSON-COOK ESOPHAGEAL MOTILITY CATHETER Wilson-Cook Medical, Inc. | KLA |
| Feb 28, 1989 | K884527 | ZINETICS(R) EMC Zinetics Medical, Inc. | KLA |
| Oct 12, 1988 | K882551 | AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 Intl. Biomedics, Inc. | KLA |
| Mar 18, 1988 | K872712 | PC POLYGRAF Synectics-Dantec | KLA |
| Jun 22, 1982 | K821588 | SANDHILL DMS Sandhill | KLA |
| Nov 22, 1977 | K771723 | HILL TUBE Physio-Control Corp. | KLA |
| Nov 22, 1977 | K771265 | PRESSURE MONITOR MANOMETRIC SYS. Physio-Control Corp. | KLA |
| May 20, 1977 | K770785 | MONITOR, RESPIRATORY, TWO-GAS, RDC Research Development Corp. | KLA |
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