| Device Type ID | 5647 |
| Device Name | Unit, Cryosurgical, Accessories |
| Regulation Description | Cryosurgical Unit And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GEH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5647 |
| Device | Unit, Cryosurgical, Accessories |
| Product Code | GEH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cryosurgical Unit And Accessories. |
| CFR Regulation Number | 878.4350 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ATRICURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BOVIE MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C2 THERAPEUTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
COOL RENEWAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CRYOFOS MEDICAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CSA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 10 | |
ERBE ELEKTROMEDIZIN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ERBE USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GALIL MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
GALIL MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GALIL MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HEALTHTRONICS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HEALTHTRONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUANCE MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRESTIGE BRANDS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
YONMEDICAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 218 |
Insulation | 172 |
Adverse Event Without Identified Device Or Use Problem | 117 |
Appropriate Term/Code Not Available | 37 |
Fire | 10 |
Insufficient Information | 10 |
Needle | 7 |
Device Operational Issue | 7 |
Gas Leak | 7 |
Misconnection | 6 |
No Apparent Adverse Event | 6 |
Computer Software Problem | 6 |
Device Displays Incorrect Message | 5 |
Failure To Fire | 5 |
Electrical /Electronic Property Problem | 4 |
Connection Problem | 3 |
Activation Problem | 2 |
Inflation Problem | 2 |
Material Rupture | 2 |
Difficult Or Delayed Activation | 2 |
Noise, Audible | 2 |
Unsealed Device Packaging | 2 |
Computer Operating System Problem | 2 |
Device Handling Problem | 1 |
Incorrect Interpretation Of Signal | 1 |
Material Separation | 1 |
Material Fragmentation | 1 |
Partial Blockage | 1 |
Leak / Splash | 1 |
Device Maintenance Issue | 1 |
Pressure Problem | 1 |
Missing Value Reason | 1 |
Display | 1 |
Filter | 1 |
Break | 1 |
Crack | 1 |
Display Or Visual Feedback Problem | 1 |
Fluid Leak | 1 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
Improper Flow Or Infusion | 1 |
Output Problem | 1 |
Temperature Problem | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Free Or Unrestricted Flow | 1 |
Thermal Decomposition Of Device | 1 |
Device Damaged Prior To Use | 1 |
Restricted Flow Rate | 1 |
Human-Device Interface Problem | 1 |
Infusion Or Flow Problem | 1 |
Operating System Becomes Nonfunctional | 1 |
Hose Line Rupture | 1 |
Bent | 1 |
Burst Container Or Vessel | 1 |
Material Integrity Problem | 1 |
Device Inoperable | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
No Display / Image | 1 |
Gas Output Problem | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Component Missing | 1 |
Increase In Pressure | 1 |
Device Difficult To Program Or Calibrate | 1 |
Shaft | 1 |
Insufficient Cooling | 1 |
Difficult Or Delayed Positioning | 1 |
| Total Device Problems | 678 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Atricure Inc | II | Dec-30-2014 |
| 2 | C2 Therapeutics, Inc. | II | Jun-05-2018 |
| 3 | C2 Therapeutics, Inc. | II | Mar-15-2017 |
| 4 | CSA Medical | II | Apr-23-2015 |
| 5 | CSA Medical | II | Jan-07-2015 |
| 6 | CooperSurgical, Inc. | II | Apr-16-2015 |
| 7 | PENTAX Of America Inc | II | Mar-01-2019 |