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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluid jet removal system
Definition The system is used for removal of prostate tissue with a fluid jet.
Product CodePZP
Regulation Number 876.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
PROCEPT BIOROBOTICS
  SUBSTANTIALLY EQUIVALENT 1
PROCEPT BIOROBOTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
  GRANTED 1

MDR Year MDR Reports MDR Events
2018 14 14
2019 70 70
2020 85 85
2021 99 99
2022 174 174
2023 254 254
2024 224 224

Recalls
Manufacturer Recall Class Date Posted
1 PROCEPT BIOROBOTICS CORPORATION II Aug-20-2021
2 PROCEPT BIOROBOTICS CORPORATION II Apr-08-2019
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