| Device Type ID | 1703 |
| Device Name | Stylet For Catheter, Gastro-urology |
| Regulation Description | Urological Catheter 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) Exempt |
| CFR Regulation Number | 876.5130 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EZB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1703 |
| Device | Stylet For Catheter, Gastro-urology |
| Product Code | EZB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Device Damaged By Another Device | 52 |
Break | 48 |
Detachment Of Device Component | 37 |
Material Integrity Problem | 34 |
Tip | 33 |
Guidewire | 32 |
Material Deformation | 17 |
Wire | 11 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Core | 5 |
Flaked | 5 |
Bent | 4 |
Unraveled Material | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Device Packaging Compromised | 2 |
Material Protrusion / Extrusion | 2 |
Off-Label Use | 2 |
Entrapment Of Device | 2 |
Seal | 2 |
Material Twisted / Bent | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Product Quality Problem | 1 |
Fracture | 1 |
Deflation Problem | 1 |
No Apparent Adverse Event | 1 |
Device Damaged Prior To Use | 1 |
Positioning Problem | 1 |
Defective Device | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Peeled / Delaminated | 1 |
| Total Device Problems | 312 |