| Device Type ID | 1991 |
| Device Name | Lithotriptor, Biliary Mechanical |
| Regulation Description | Mechanical Lithotriptor. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.4500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LQC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1991 |
| Device | Lithotriptor, Biliary Mechanical |
| Product Code | LQC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Mechanical Lithotriptor. |
| CFR Regulation Number | 876.4500 [🔎] |
| Device Problems | |
|---|---|
Break | 214 |
Material Deformation | 130 |
Guide | 127 |
Wire | 81 |
Tip | 67 |
Difficult To Remove | 41 |
Detachment Of Device Or Device Component | 32 |
Separation Failure | 29 |
Device Handling Problem | 28 |
Handpiece | 22 |
Detachment Of Device Component | 11 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Device Operates Differently Than Expected | 5 |
Difficult To Open Or Close | 4 |
Premature Activation | 4 |
Defective Device | 4 |
Use Of Device Problem | 3 |
Material Twisted / Bent | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Fracture | 2 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Deformation Due To Compressive Stress | 1 |
Entrapment Of Device | 1 |
Device-Device Incompatibility | 1 |
Unsealed Device Packaging | 1 |
Off-Label Use | 1 |
| Total Device Problems | 825 |