AquaBeam System
Catalogue number 210101, listed by Procept BioRobotics Corporation, United States, under Fluid Jet Removal System. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
9510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Procept BioRobotics Corporation, United States |
|---|---|
| FDA product code | PZP |
| Device type | Fluid Jet Removal System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4350 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | DEN170024 |
| Record published | 2018-01-11 |
| Record revised | 2026-01-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 210101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AquaBeam Handpiece | Procept BioRobotics Corporation | 6 |
| AquaBeam Robotic System | Procept BioRobotics Corporation | 3 |
| AquaBeam Scope | Procept BioRobotics Corporation | 3 |
| Hydros Robotic System | Procept BioRobotics Corporation | 1 |
| Hydros Handpiece | Procept BioRobotics Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260723 | 2026-07-09 |
| K253211 | 2026-06-23 |
| K251082 | 2025-10-10 |
| K241952 | 2024-09-30 |
| K240200 | 2024-08-20 |
| K231024 | 2023-08-30 |
| K212835 | 2021-10-06 |
| K202961 | 2021-03-11 |
| DEN170024 | 2017-12-21 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-07-09 | Class II | Component change control | Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay fo | 608 | |
| 2019-03-06 | Class II | Process control | Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which m | 214 | 2020-11-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.