HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece is an AI-enabled medical device from Procept BioRobotics that the U.S. FDA cleared through 510(k) K240200 on August 20, 2024. Its lead review panel is General and Plastic Surgery and its primary product code is PZP (Fluid Jet Removal System).
See also all FDA AI clearances in 2024.
Key facts
| Submission number | K240200 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Procept BioRobotics |
| Lead review panel | General and Plastic Surgery |
| Primary product code | PZP — Fluid Jet Removal System |
| Applicant (openFDA) | Procept Biorobotics |
| Applicant location | San Jose, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 876.4350 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece went through this pathway (K240200).
openFDA lists it as a Class 2 device under 21 CFR 876.4350. Class II devices are moderate risk and are subject to general and special controls.
Product code PZP covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Procept BioRobotics has 2 AI-enabled devices on the list, and the General and Plastic Surgery panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.