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FDA PRODUCT CODE · CLASS II

PZP — Fluid Jet Removal System

The system is used for removal of prostate tissue with a fluid jet.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.4350
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K260723Procept Biorobotics · 510k2026-07-09
K253211Procept Biorobotics · 510k2026-06-23
K251082Procept Biorobotics · 510k2025-10-10
K241952Procept Biorobotics · 510k2024-09-30

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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