Definition: To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (8
| Device Type ID | 1819 |
| Device Name | Ureteroscope And Accessories, Flexible/rigid |
| Physical State | Endoscope, Associated Accessories |
| Technical Method | Inserted Into Blood Urinary Tract Through Urethra |
| Target Area | Urinary Tract |
| Regulation Description | Endoscope And Accessories. |
| 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) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FGB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1819 |
| Device | Ureteroscope And Accessories, Flexible/rigid |
| Product Code | FGB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KARL STORZ SE & CO KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO, LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Break | 75 |
Endoscope | 71 |
Microbial Contamination Of Device | 32 |
No Display / Image | 30 |
Adverse Event Without Identified Device Or Use Problem | 21 |
Leak / Splash | 19 |
Material Protrusion / Extrusion | 17 |
Material Deformation | 14 |
Mechanical Problem | 13 |
Poor Quality Image | 9 |
Device Damaged Prior To Use | 8 |
Tip | 8 |
Fracture | 8 |
No Device Output | 7 |
Material Perforation | 7 |
Material Fragmentation | 6 |
Difficult To Remove | 6 |
Tear, Rip Or Hole In Device Packaging | 6 |
Improper Device Output | 5 |
Bent | 5 |
Contamination / Decontamination Problem | 5 |
Device Handling Problem | 5 |
Detachment Of Device Component | 5 |
False Device Output | 4 |
Device Damaged By Another Device | 4 |
Display Or Visual Feedback Problem | 4 |
Cut In Material | 4 |
Kinked | 4 |
Mechanical Jam | 3 |
Hole In Material | 3 |
Optical Problem | 3 |
Device Operates Differently Than Expected | 3 |
Material Integrity Problem | 2 |
Material Frayed | 2 |
Melted | 2 |
Image Display Error / Artifact | 2 |
Peeled / Delaminated | 2 |
Device Contamination With Biological Material | 2 |
Entrapment Of Device | 2 |
Crack | 2 |
Misfocusing | 1 |
Difficult To Position | 1 |
Defective Device | 1 |
Output Problem | 1 |
Difficult To Advance | 1 |
Material Distortion | 1 |
Material Rupture | 1 |
Fiber | 1 |
Thermal Decomposition Of Device | 1 |
Erratic Or Intermittent Display | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Aspiration Issue | 1 |
Device Maintenance Issue | 1 |
Partial Blockage | 1 |
Unsealed Device Packaging | 1 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Lenses | 1 |
Degraded | 1 |
Device Displays Incorrect Message | 1 |
Shaft | 1 |
Power Problem | 1 |
Contamination During Use | 1 |
Corroded | 1 |
Image Resolution Poor | 1 |
Device Operational Issue | 1 |
Material Twisted / Bent | 1 |
Material Disintegration | 1 |
| Total Device Problems | 462 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Olympus Corporation Of The Americas | II | Jul-20-2018 |
| 2 | Pentax Medical Company | II | Jun-28-2016 |