FDA product code PZP: Fluid Jet Removal System
PZP is the FDA product code for fluid jet removal system. It is a Class II device, regulated under 21 CFR 876.4350 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under PZP, 6 in the last five years, from 2 different applicants. The average 510(k) review took 151 days (median 152); 176 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for PZP devices.
Definition
The system is used for removal of prostate tissue with a fluid jet.
Classification
| Field | Value |
|---|---|
| Device name | Fluid Jet Removal System |
| Device class | Class II |
| Regulation | 21 CFR 876.4350 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PZP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 2 | 96 |
| 2023 | 1 | 141 |
| 2024 | 2 | 148 |
| 2025 | 1 | 184 |
| 2026 | 2 | 196 |
Compare with all 510(k) review times · Search every PZP clearance
Top PZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Procept Biorobotics | 5 | 2026-07-09 |
| Procept Biorobotics, Corporation | 3 | 2023-08-30 |
Most recent PZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260723 | Procept Biorobotics | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | 2026-07-09 | 126 |
| K253211 | Procept Biorobotics | AQUABEAM Robotic System | 2026-06-23 | 267 |
| K251082 | Procept Biorobotics | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | 2025-10-10 | 184 |
| K241952 | Procept Biorobotics | AQUABEAM Robotic System (AB2000) | 2024-09-30 | 89 |
| K240200 | Procept Biorobotics | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | 2024-08-20 | 208 |
Recalls for PZP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-07-09.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code PZP?
PZP is the FDA product code for fluid jet removal system. It is a Class II device, regulated under 21 CFR 876.4350 and reviewed by the Gastroenterology and Urology panel.
What device class is PZP?
Class II, regulation 21 CFR 876.4350. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZP?
Across 8 cleared submissions the average was 151 days from receipt to decision (median 152).
Which companies have the most PZP clearances?
Procept Biorobotics (5); Procept Biorobotics, Corporation (3).
Have PZP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2021-07-09.
Next steps
- Run an FDA pathway report with predicate devices for product code PZP
- Run a recall and safety report across every PZP manufacturer
- Watch product code PZP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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