Definition: To Examine And Perform 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 (82 FR 26807, Available A
| Device Type ID | 1722 |
| Device Name | Cystoscope And Accessories, Flexible/rigid |
| Physical State | Endoscope, Accessories Associated With Cystoscope |
| Technical Method | Intrument Guided Through Urethra For Visualization And To Perform Various Procedures. |
| Target Area | Bladder, Urethra, Kidneys |
| 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 | FAJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1722 |
| Device | Cystoscope And Accessories, Flexible/rigid |
| Product Code | FAJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMBU A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMBU INTERNATIONAL A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 81 |
Adverse Event Without Identified Device Or Use Problem | 65 |
Endoscope | 28 |
Insufficient Information | 23 |
Contamination / Decontamination Problem | 14 |
Device Reprocessing Problem | 12 |
Appropriate Term/Code Not Available | 11 |
Break | 8 |
Material Fragmentation | 4 |
No Display / Image | 4 |
No Apparent Adverse Event | 3 |
Device Disinfection Or Sterilization Issue | 3 |
Loose Or Intermittent Connection | 2 |
Detachment Of Device Or Device Component | 2 |
No Device Output | 2 |
Hole In Material | 2 |
Material Deformation | 2 |
Difficult To Remove | 2 |
Device Operates Differently Than Expected | 1 |
Optical Discoloration | 1 |
Material Disintegration | 1 |
Fracture | 1 |
Cap | 1 |
Degraded | 1 |
Melted | 1 |
Use Of Device Problem | 1 |
Deformation Due To Compressive Stress | 1 |
Connection Problem | 1 |
Fail-Safe Problem | 1 |
Failure To Fold | 1 |
Detachment Of Device Component | 1 |
Peeled / Delaminated | 1 |
Device Contamination With Biological Material | 1 |
Device Issue | 1 |
Folded | 1 |
Device Handling Problem | 1 |
Collapse | 1 |
Crack | 1 |
Entrapment Of Device | 1 |
| Total Device Problems | 289 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Customed, Inc | II | Apr-14-2016 |
| 2 | Customed, Inc | II | Sep-03-2015 |
| 3 | Pentax Medical Company | II | Jun-28-2016 |
| 4 | Pentax Of America Inc | II | Feb-14-2018 |