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AquaBeam Scope 210501

by PROCEPT BioRobotics Corporation

Ref SC2000

AquaBeam Scope 210501 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 0850055427SC2000MF), cleared under FDA 510(k) K241952 on 30 Sep 2024 (2 earlier submissions) and granted FDA De Novo DEN170024 on 21 Dec 2017 and in 1 more registry, active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241952

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850055427SC2000MF Basic UDI-DI 00850055427013UDI-DIDate15 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK241952 Date30 Sep 2024DecidedStatusActive
United StatesGUDID listing GUDID Number00850055427013 UDI-DI Date11 Jan 2018ListedStatusListed 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 0850055427SC2000MF registered 15 May 2026 Active
  • FDA 510(k) K241952 decided 30 Sep 2024 Active· +2 more in the status table
  • FDA De Novo DEN170024 decided 21 Dec 2017 Active
  • FDA GUDID UDI-DI 00850055427013 listed 11 Jan 2018 Listed

Timeline

6 dated events

  1. Granted FDA De Novo DEN170024
  2. Listed FDA GUDID 00850055427013
  3. Cleared FDA 510(k) K212835
  4. Cleared FDA 510(k) K231024
  5. Cleared FDA 510(k) K241952
  6. Registered EUDAMED 0850055427SC2000MF

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  • Withdrawn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 Scope
Generic name
Rigid endoscope telescope
Model / Ref / Catalog
SC2000, 210501, SC2000-D
Primary DI / UDI-DI
00850055427013, B6142105011
Basic UDI-DI
0850055427SC2000MF
Direct marketing DI
00850055427013
510(k) Number
De Novo Number
FDA product code
PZP
EMDN code
Z12020701 Cystoscopes
GMDN term
Rigid endoscope telescope
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: Rigid endoscope telescope

Cleared under the same submission (DEN170024)

and 2 more cleared under DEN170024

Similar devices in this category

Other devices filed under CYSTOSCOPES.

Other devices from PROCEPT BioRobotics Corporation

See all devices from PROCEPT BioRobotics Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number NoGUDIDYesGUDID
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)