THD PressKit (TR BOX)
by Thd SpA
THD PressKit (TR BOX) (800142) is a Class II device made by Thd SpA, cleared under FDA 510(k) K161785 on 14 Mar 2017 and listed in FDA GUDID since 20 Sep 2017 (UDI-DI 08033737711262), active as of 23 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 | Number08033737711262 | Date20 Sep 2017 | StatusListed |
| United States | FDA 510(k) | NumberK161785 | Date14 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 08033737711262
- FDA 510(k) database K161785
Across registries
- FDA 510(k) K161785 decided 14 Mar 2017 Active
- FDA GUDID UDI-DI 08033737711262 listed 20 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K161785
- Listed FDA GUDID 08033737711262
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- THD PressKit
- Generic name
- Gastrointestinal motility manometric catheter, non-electronic
- Model / Ref / Catalog
- THD PressKit (TR BOX), 800142
- Primary DI / UDI-DI
- 08033737711262
- 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
- Weight — 25 GramOuter Diameter — 16 MillimeterLength — 165 Millimeter
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- 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.