THD PressKit (FL ENV)
by Thd SpA
THD PressKit (FL ENV) (800146) 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 21 Sep 2017 (UDI-DI 08033737711309), 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 | Number08033737711309 | Date21 Sep 2017 | StatusListed |
| United States | FDA 510(k) | NumberK161785 | Date14 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 08033737711309
- FDA 510(k) database K161785
Across registries
- FDA 510(k) K161785 decided 14 Mar 2017 Active
- FDA GUDID UDI-DI 08033737711309 listed 21 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K161785
- Listed FDA GUDID 08033737711309
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- Withdrawn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 (FL ENV), 800146
- Primary DI / UDI-DI
- 08033737711309
- 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 — 165 MillimeterOuter Diameter — 16 MillimeterWeight — 25 Gram
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- Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Anorectal Pressure Catheter, Model GIA-8500 by Clinical Innovations, LLC