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HYDROS TRUS Probe HU1000

by PROCEPT BioRobotics Corporation

Ref HU1000

HYDROS TRUS Probe HU1000 is a rectal/vaginal ultrasound imaging transducer (EU MDR Class IIa; FDA Class II; FDA product code ITX, Transducer, ultrasonic, diagnostic) made by PROCEPT BioRobotics Corporation, registered in EUDAMED on 14 May 2026 (Basic UDI-DI 0850055427HU1000NX), cleared under FDA 510(k) K240200 on 20 Aug 2024 and listed in FDA GUDID since 6 Sep 2024 (UDI-DI 00850055427075), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240200

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850055427HU1000NX Basic UDI-DI 00850055427075UDI-DIDate14 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850055427075 UDI-DI Date6 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240200 Date20 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0850055427HU1000NX registered 14 May 2026 Active
  • FDA 510(k) K240200 decided 20 Aug 2024 Active
  • FDA GUDID UDI-DI 00850055427075 listed 6 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240200
  2. Listed FDA GUDID 00850055427075
  3. Registered EUDAMED 0850055427HU1000NX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
HYDROS TRUS Probe
Generic name
Rectal/vaginal ultrasound imaging transducer
Model / reference
HU1000
Primary DI / UDI-DI
00850055427075
Basic UDI-DI
0850055427HU1000NX
Direct marketing DI
00850055427075
FDA product code
ITX
EMDN code
Z1104020201 Endocavitary ultrasound probes, two–dimensional
GMDN term
Rectal/vaginal ultrasound imaging transducer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Hydrogen Peroxide
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Rectal/vaginal ultrasound imaging transducer

Cleared under the same submission (K240200)

Similar devices in this category

Other devices filed under ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL.

Other devices from PROCEPT BioRobotics Corporation

See all devices from PROCEPT BioRobotics Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)