Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device high intensity ultrasound system for prostate tissue ablation
Regulation Description High intensity ultrasound system for prostate tissue ablation.
Definition Prostate tissue ablation
Product CodePLP
Regulation Number 876.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
INSIGHTEC, INC
  SUBSTANTIALLY EQUIVALENT 1
INSIGHTEC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROFOUND MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K202286  Tulsa-Pro System
PROFOUND MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
PROFOUND MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 6 6
2023 6 6
2024 10 10
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Use of Device Problem 5 5
Insufficient Information 2 2
Device Handling Problem 2 2
Inadequate or Insufficient Training 2 2
Output Problem 1 1
Output above Specifications 1 1
Difficult to Insert 1 1
Use of Incorrect Control/Treatment Settings 1 1
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fistula 16 16
No Clinical Signs, Symptoms or Conditions 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematuria 1 1
Perforation 1 1
Urethral Stenosis/Stricture 1 1
Nerve Damage 1 1
Urinary Retention 1 1
Fibrosis 1 1

-
-