Mediplus 2386
Mediplus 2386 is a Class II device made by Mediplus, Ltd., cleared under FDA 510(k) K031617 on 16 Jan 2004 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055140700865), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055140700865 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031617 | Date16 Jan 2004 | StatusActive |
Official records
- AccessGUDID record 05055140700865
- FDA 510(k) database K031617
Across registries
- FDA 510(k) K031617 decided 16 Jan 2004 Active
- FDA GUDID UDI-DI 05055140700865 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K031617
- Listed FDA GUDID 05055140700865
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mediplus
- Generic name
- Gastrointestinal motility manometric catheter, non-electronic
- Model / reference
- 2386
- Primary DI / UDI-DI
- 05055140700865
- 510(k) Number
- FDA product code
- KLA
- GMDN term
- Gastrointestinal motility manometric catheter, non-electronic
- Device class
- Class II
- Regulation number
- 876.1725
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 150.0 CentimeterOuter Diameter — 4.9 Millimeter
Similar devices
Other devices filed under FDA product code KLA (MONITOR, ESOPHAGEAL MOTILITY, AND TUBE).
- SANDHILL DMS by Sandhill
- SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS by Sarmed Srl
- MONOCRYSTANT PH/LES CATHETER, MODIFICATION by Synectics-Dantec
- PC POLYGRAF by Synectics-Dantec
- CLA-COMPUTERIZED LARYNGEAL ANALYZER by H.I.L. Research, Ltd.
- FLEXILOG 3000 by Oakfield Instruments, Ltd.
- AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 by Intl. Biomedics, Inc.
- Solar Anorectal Manometry Catheter (Model K1210AC-L-2212) by Laborie Medical Technologies Corp.
- PRESSURE MONITOR MANOMETRIC SYS. by PHYSIO-CONTROL, Inc.
- ANALGRAPH by Sandhill Scientific, Inc.