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AquaBeam Handpiece HP2000

by PROCEPT BioRobotics Corporation 2 variants

Ref HP2000

AquaBeam Handpiece HP2000 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 0850055427HP2000MF), cleared under FDA 510(k) K241952 on 30 Sep 2024 (2 earlier submissions) and listed in FDA GUDID since 31 May 2022 (UDI-DI 00850055427006), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241952

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850055427HP2000MF Basic UDI-DI 00850055427006UDI-DIDate15 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK241952 Date30 Sep 2024DecidedStatusActive
United StatesGUDID listing GUDID Number00850055427006 UDI-DI Date31 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0850055427HP2000MF registered 15 May 2026 Active
  • FDA 510(k) K241952 decided 30 Sep 2024 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00850055427006 listed 31 May 2022 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K212835
  2. Listed FDA GUDID 00850055427006
  3. Cleared FDA 510(k) K231024
  4. Cleared FDA 510(k) K241952
  5. Registered EUDAMED 0850055427HP2000MF

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  • Withdrawn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
AquaBeam Handpiece
Generic name
Water jet knife system handpiece, single-use
Model / Ref / Catalog
HP2000, HP2000-D
Primary DI / UDI-DI
00850055427006, B614HP2000X1
Basic UDI-DI
0850055427HP2000MF
510(k) Number
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
Yes
No

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 (K212835)

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 YesEUDAMEDGUDIDNoGUDID
  • Single use NoGUDIDYesGUDID
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number NoGUDIDYesGUDID
  • Serial number YesGUDIDNoGUDID
  • Expiration date NoGUDIDYesGUDID
  • Manufacturing date YesGUDIDNoGUDID
Other properties (17, all answered No)