Identity
- Trade Name
- AquaBeam Scope EUDAMEDFDA UDI
- Generic Name
- Rigid endoscope telescope FDA UDI
- Device Name
- AquaBeam Scope EUDAMED
- Model / Reference
- SC2000 EUDAMEDFDA UDI210501 FDA UDI
Identifiers
- Catalog Number
- 210501 FDA UDISC2000-D FDA UDI
- Primary DI / UDI-DI
- 00850055427013 EUDAMEDFDA UDIB6142105011 FDA UDI
- Basic UDI-DI
- 0850055427SC2000MF EUDAMED
- Direct Marketing DI
- 00850055427013 EUDAMED
- FDA Product Code
- PZP FDA UDI
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
- GMDN Term
- Rigid endoscope telescope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4350 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDIFDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Rigid endoscope telescope
AquaBeam Scope by PROCEPT BioRobotics Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope telescope.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class I
- Olympus — Olympus Winter & Ibe GmbH · Class II
- PANOVIEW PLUS HD — Richard Wolf GmbH · Class II
- PANOVIEW PLUS — Richard Wolf GmbH · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Cleared under the same submission
DEN170024 also covers:
- AquaBeam Handpiece — PROCEPT BioRobotics Corporation
- AquaBeam Handpiece — PROCEPT BioRobotics Corporation
- AquaBeam Robotic System — PROCEPT BioRobotics Corporation
- AquaBeam Robotic System — PROCEPT BioRobotics Corporation
- AquaBeam Scope — PROCEPT BioRobotics Corporation
- AquaBeam System — PROCEPT BioRobotics Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PROCEPT BioRobotics Corporation
Sources (3)
- FDA UDI 63d23ae5-f5c2-4c65-9329-795583d07649 34 fields · synced Aug 4, 2026
- FDA UDI 57652011-a500-465d-9c43-4d6f3af68c17 36 fields · synced May 30, 2026
- EUDAMED 670d26c2-4cfb-4505-bd19-6d9a5fa58d52 61 fields · synced Aug 4, 2026