FDA Product Code
FDA Product Code KLA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1725
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | 2025-02-12 | Traditional | PDF ↗ |
| K242304 | RED | Neuraxis, Inc. | 2024-12-06 | Traditional | PDF ↗ |
| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | Laborie Medical Technologies, Corp. | 2024-04-23 | Traditional | PDF ↗ |
| K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018-03-08 | Traditional | PDF ↗ |
| K161785 | THD ANOPRESS | Thd Spa | 2017-03-14 | Traditional | PDF ↗ |
| K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015-07-07 | Traditional | PDF ↗ |
| K120088 | MCOMPASS ANORECTAL MANOMETRY SYSTEM | Medspira, LLC | 2012-03-29 | Traditional | PDF ↗ |
| K062362 | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS | Sarmed Srl | 2007-04-13 | Traditional | PDF ↗ |
| K031617 | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER | Mediplus , Ltd. | 2004-01-16 | Traditional | PDF ↗ |
| K032138 | MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER | Medtronic Vascular | 2003-10-09 | Traditional | PDF ↗ |
| K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 | Clinical Innovations, Inc. | 2003-01-07 | Traditional | PDF ↗ |
| K013704 | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER | Mediplus , Ltd. | 2002-08-05 | Traditional | PDF ↗ |
| K983665 | MANOMETRIC ASSEMBLIES | Dentsleeve Pty., Ltd. | 1999-05-17 | Traditional | PDF ↗ |
| K964804 | FLEXILOG LS | Oakfield Instruments, Ltd. | 1997-08-06 | Traditional | PDF ↗ |
| K964589 | FLEXILOG 3000 | Oakfield Instruments, Ltd. | 1997-03-04 | Traditional | PDF ↗ |
| K961895 | FLEXILOG LS 13921 | Oakfield Instruments, Ltd. | 1996-11-04 | Traditional | PDF ↗ |
| K961070 | ESOPHAGEAL MANOMETRY ANALYSIS MODULE | Synectics Medical, Inc. | 1996-06-11 | Traditional | PDF ↗ |
| K961056 | BIOVIEW MODEL S960000 | Sandhill Scientific, Inc. | 1996-06-06 | Traditional | PDF ↗ |
| K954798 | 7100 SWALLOWING WORKSTATION | Kay Elemetrics Corp. | 1996-06-04 | Traditional | PDF ↗ |
| K941801 | ANALGRAPH | Sandhill Scientific, Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K922553 | CLA-COMPUTERIZED LARYNGEAL ANALYZER | H.I.L. Research, Ltd. | 1994-08-23 | Traditional | PDF ↗ |
| K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION | Synectics-Dantec | 1993-12-13 | Traditional | PDF ↗ |
| K901125 | PROVOCATIVE SENSITIVITY BALLOON | Wilson-Cook Medical, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K900239 | WILSON-COOK ESOPHAGEAL MOTILITY CATHETER | Wilson-Cook Medical, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K884527 | ZINETICS(R) EMC | Zinetics Medical, Inc. | 1989-02-28 | Traditional | PDF ↗ |
| K882551 | AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 | Intl. Biomedics, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K872712 | PC POLYGRAF | Synectics-Dantec | 1988-03-18 | Traditional | PDF ↗ |
| K821588 | SANDHILL DMS | Sandhill | 1982-06-22 | Traditional | PDF ↗ |
| K771265 | PRESSURE MONITOR MANOMETRIC SYS. | Physio-Control Corp. | 1977-11-22 | Traditional | PDF ↗ |
| K771723 | HILL TUBE | Physio-Control Corp. | 1977-11-22 | Traditional | PDF ↗ |
| K770785 | MONITOR, RESPIRATORY, TWO-GAS, RDC | Research Development Corp. | 1977-05-20 | Traditional | PDF ↗ |
Product code KLA · Class II · Gastroenterology, Urology. Data: openFDA.