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HYDROS Handpiece HH1000

by PROCEPT BioRobotics Corporation

Ref HH1000

HYDROS Handpiece HH1000 is a device classified as Class IIa in the EU and Class II in the US made by PROCEPT BioRobotics Corporation, registered in EUDAMED on 15 May 2026 (Basic UDI-DI 0850055427HH1000JG), cleared under FDA 510(k) K240200 on 20 Aug 2024 and listed in FDA GUDID since 6 Sep 2024 (UDI-DI 00850055427051), active as of 22 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 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850055427HH1000JG Basic UDI-DI 00850055427051UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850055427051 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 0850055427HH1000JG registered 15 May 2026 Active
  • FDA 510(k) K240200 decided 20 Aug 2024 Active
  • FDA GUDID UDI-DI 00850055427051 listed 6 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240200
  2. Listed FDA GUDID 00850055427051
  3. Registered EUDAMED 0850055427HH1000JG

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  • Withdrawn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 Handpiece
Generic name
Water jet knife system handpiece, single-use
Model / reference
HH1000
Primary DI / UDI-DI
00850055427051
Basic UDI-DI
0850055427HH1000JG
FDA product code
PZP
EMDN code
Z120106 Hydrodissectors
GMDN term
Water jet knife system handpiece, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.4350
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
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: Water jet knife system handpiece, single-use

Cleared under the same submission (K240200)

Similar devices in this category

Other devices filed under GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS.

Other devices from PROCEPT BioRobotics Corporation

See all devices from PROCEPT BioRobotics Corporation →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)