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THD PressKit (TR ENV)

by Thd SpA

THD PressKit (TR ENV) (800145) 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 08033737711293), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K161785

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08033737711293 UDI-DI Date21 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK161785 Date14 Mar 2017IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161785 decided 14 Mar 2017 Active
  • FDA GUDID UDI-DI 08033737711293 listed 21 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161785
  2. Listed FDA GUDID 08033737711293

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
THD PressKit
Generic name
Gastrointestinal motility manometric catheter, non-electronic
Model / Ref / Catalog
THD PressKit (TR ENV), 800145
Primary DI / UDI-DI
08033737711293
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 Gram
Outer Diameter — 16 Millimeter
Length — 165 Millimeter

Related devices

Category: Gastrointestinal motility manometric catheter, non-electronic

Cleared under the same submission (K161785)

and 2 more cleared under K161785

Similar devices

Other devices filed under FDA product code KLA (Monitor, Esophageal Motility, And Tube).

Other devices from Thd SpA

See all devices from Thd SpA →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)