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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, cryosurgical, accessories
Regulation Description Cryosurgical unit and accessories.
Product CodeGEH
Regulation Number 878.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
BIBAWO MEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRYMILL CRYOGENIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CRYOCONCEPTS LP
  SUBSTANTIALLY EQUIVALENT 5
CRYOSURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 3
CSA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DGI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ENDOCISION TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HYGEA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICECURE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL BRANDS LABORATORIES B.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDILINK A/S
  SUBSTANTIALLY EQUIVALENT 1
MEDINUX (TIANJIN) TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
NUANCE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
PRONOVA LABORATORIES BV
  SUBSTANTIALLY EQUIVALENT 1
R2 TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RECENS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
RECENSMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
RECENSMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THE OTC LAB HEALTHCARE B.V.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
YOZMA BMTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 277 278
2021 213 214
2022 230 230
2023 164 164
2024 141 144
2025 64 83

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 219 219
Thermal Decomposition of Device 107 107
Appropriate Term/Code Not Available 87 87
Insufficient Cooling 86 86
Gas/Air Leak 84 84
Defective Device 81 81
Leak/Splash 58 58
Mechanical Problem 56 56
Break 55 55
Defective Component 45 45
Insufficient Heating 44 44
Insufficient Information 31 31
Use of Device Problem 28 28
Output Problem 25 25
Temperature Problem 21 21
Physical Resistance/Sticking 18 18
Material Twisted/Bent 18 18
Noise, Audible 16 16
Therapeutic or Diagnostic Output Failure 14 14
Failure to Fire 13 13
Crack 11 11
Loose or Intermittent Connection 9 9
Material Separation 9 9
Fluid/Blood Leak 8 8
Explosion 8 8
Improper or Incorrect Procedure or Method 8 8
Difficult to Remove 8 8
Free or Unrestricted Flow 8 32
No Apparent Adverse Event 6 6
Contamination 6 6
Device Alarm System 6 6
Gas Output Problem 6 6
Material Deformation 6 6
Expulsion 6 6
Display or Visual Feedback Problem 5 5
Fire 5 5
Burst Container or Vessel 5 5
Pressure Problem 5 5
Infusion or Flow Problem 5 5
Detachment of Device or Device Component 4 4
Device Handling Problem 4 4
Material Rupture 4 4
Fracture 4 4
Naturally Worn 4 4
Difficult to Open or Close 4 4
Excessive Cooling 4 4
No Display/Image 4 4
Device Displays Incorrect Message 4 4
Mechanical Jam 4 4
Failure to Shut Off 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 409 431
Insufficient Information 125 133
Muscle Spasm(s) 71 71
No Consequences Or Impact To Patient 59 59
Burn(s) 44 44
Hemorrhage/Bleeding 40 40
No Known Impact Or Consequence To Patient 39 39
Fistula 32 32
Pain 30 30
Pneumothorax 27 27
Necrosis 19 19
Superficial (First Degree) Burn 18 18
Epistaxis 18 18
Cramp(s) /Muscle Spasm(s) 18 18
Partial thickness (Second Degree) Burn 17 17
Cryogenic Burn 16 18
No Code Available 16 16
Hematoma 16 16
Pleural Effusion 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Renal Failure 14 14
Laceration(s) 14 14
Full thickness (Third Degree) Burn 13 13
Unspecified Infection 12 12
Perforation 11 11
Dyspnea 10 10
Obstruction/Occlusion 10 10
Blood Loss 10 10
Incontinence 10 10
Arrhythmia 9 9
Respiratory Failure 9 9
Caustic/Chemical Burns 8 8
Swelling/ Edema 8 8
Urinary Retention 8 8
Cardiac Arrest 8 8
Fatigue 7 7
Hematuria 7 7
Discomfort 7 7
Hemoptysis 6 6
Nerve Damage 6 6
Foreign Body In Patient 6 6
Urinary Tract Infection 6 6
Cancer 5 5
Pseudoaneurysm 5 5
Air Embolism 5 5
Bowel Perforation 5 5
Blister 5 7
Stroke/CVA 5 5
Perforation of Esophagus 5 5
Abdominal Distention 5 5

Recalls
Manufacturer Recall Class Date Posted
1 AtriCure, Inc. II Jan-31-2024
2 Boston Scientific Corporation II Apr-29-2025
3 Boston Scientific Corporation II Dec-22-2020
4 Boston Scientific Corporation II Oct-23-2020
5 Boston Scientific Corporation II Jul-21-2020
6 Icecure Medical Ltd II Sep-29-2023
7 New Medical Technologies Gmbh II Feb-05-2025
8 OraSure Technologies, Inc. III Sep-23-2020
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