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AquaBeam Robotic System AB2000

by PROCEPT BioRobotics Corporation

Ref AB2000

AquaBeam Robotic System AB2000 is a device classified as Class IIb in the EU and Class II in the US made by PROCEPT BioRobotics Corporation, registered in EUDAMED on 18 May 2026 (Basic UDI-DI 0850055427AB2000DS), cleared under FDA 510(k) K241952 on 30 Sep 2024 (1 earlier submission) and granted FDA De Novo DEN170024 on 21 Dec 2017 and in 1 more registry, active as of 22 Oct 2026.

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

CE MDR 510(k) De Novo

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) K241952

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850055427AB2000DS Basic UDI-DI 00850055427020UDI-DIDate18 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK241952 Date30 Sep 2024DecidedStatusActive
United StatesGUDID listing GUDID Number00850055427020 UDI-DI Date25 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG GUDID from GUDID De Novo granted · Direct NumberDEN170024 Date21 Dec 2017DecidedStatusActive

Official records

Across registries

4 registries list this device

  • EUDAMED Basic UDI-DI 0850055427AB2000DS registered 18 May 2026 Active
  • FDA 510(k) K241952 decided 30 Sep 2024 Active· +1 more in the status table
  • FDA De Novo DEN170024 decided 21 Dec 2017 Active
  • FDA GUDID UDI-DI 00850055427020 listed 25 Aug 2023 Listed

Timeline

5 dated events

  1. Granted FDA De Novo DEN170024
  2. Listed FDA GUDID 00850055427020
  3. Cleared FDA 510(k) K231024
  4. Cleared FDA 510(k) K241952
  5. Registered EUDAMED 0850055427AB2000DS

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
AquaBeam Robotic System
Generic name
Water jet knife system
Model / Ref / Catalog
AB2000, AB2000-D, AB2000-E
Primary DI / UDI-DI
00850055427020
Basic UDI-DI
0850055427AB2000DS
Direct marketing DI
00850055427020
510(k) Number
De Novo Number
FDA product code
PZP
EMDN code
Z120106 Hydrodissectors
GMDN term
Water jet knife system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.4350
System or procedure pack
System which is a device in itself
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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

Cleared under the same submission (DEN170024)

and 2 more cleared under DEN170024

Cleared under the same submission (K231024)

Similar devices

Also classified as Water jet knife system.

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

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)