General and Plastic Surgery · 510(k) · 2025
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
Procept Biorobotics. Cleared by FDA on 10 October 2025 under submission K251082, product code PZP (fluid jet removal system). What FDA's record says, in FDA's words.
Device record · K251082
- Device. HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)DEVICE
- Company. Procept BioroboticsCOMPANY
- Decision. 10 October 2025, 510(k), substantially equivalent (traditional review); received 9 April 2025DECISION
- Panel. General and Plastic SurgeryPANEL
- Product code. PZP, Fluid Jet Removal SystemCODE
- Regulation. 21 CFR 876.4350, Class IIREG
- Source. FDA database entry · decision document (27 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The HYDROS Robotic System is indicated for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia. Intended Patient Population The intended patient population is males suffering from LUTS resulting from benign prostatic hyperplasia (BPH).
The product code's definition, from FDA's classification record. The system is used for removal of prostate tissue with a fluid jet.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,491 reports filed against devices carrying product code PZP. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Injury · AQUABEAM Robotic System · PROCEPT BioRobotics Corporation · report 3012977056-2026-00199
A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics Corporation (PROCEPT) became aware that, during Focal Bladder Neck Cautery (FBNC), the patient sustained a bladder perforation. The treating surgeon indicated that the bladder perforation likely occurred during hemostasis at a thin-walled portion of the diverticulum. The bladder was repaired laparoscopically. No malfunction of the AQUABEAM Robotic System was reported.
29 September 2026 · Malfunction · HYDROS Robotic System · PROCEPT BioRobotics Corporation · report 3012977056-2026-00198
28 September 2026 · Malfunction · AQUABEAM Robotic System · PROCEPT BioRobotics Corporation · report 3012977056-2026-00197
28 September 2026 · Injury · AQUABEAM Robotic System · PROCEPT BioRobotics Corporation · report 3012977056-2026-00196
23 September 2026 · Death · AQUABEAM Robotic System · PROCEPT BioRobotics Corporation · report 3012977056-2026-00193
A male patient underwent Aquablation therapy for symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics (PROCEPT) became aware on 01-Sep-2026 that the patient had passed away. The patient experienced an acute pulmonary embolism after the first treatment pass of Aquablation therapy. The anesthesia team indicated that the patient was becoming hypotensive prior to starting the second treatment pass of Aquablation. The patient experienced cardiac arrest multiple times, and it was […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PZP, in General and Plastic Surgery, from Procept Biorobotics, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.