# PROCEPT BioRobotics Corporation (manufacturer, San Jose, CA): 4 new FDA device listings, incl. fluid jet removal system

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | PROCEPT BioRobotics Corporation |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Device in the United States for Export Only |
| Location | San Jose, CA, US |
| New listings | 4 |
| Devices | Fluid Jet Removal System; Transducer, Ultrasonic, Diagnostic |
| Product codes | PZP, ITX |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Radiology |
| Brand names | AQUABEAM Robotic System; HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) |
| First new listing | 2026-07-21 |
| Latest new listing | 2026-09-25 |
| FDA registration number | 3027788423 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.