Definition: To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.
| Device Type ID | 2066 |
| Device Name | Endoscopic Guidewire, Gastroenterology-urology |
| Physical State | Metal Guidewire With Or Without Polymer Coating, And Associated Guidewire Accessories |
| Technical Method | Placed Through Working Channel Of Endoscope |
| Target Area | Various In GI And GU 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) Exempt |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2066 |
| Device | Endoscopic Guidewire, Gastroenterology-urology |
| Product Code | OCY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCELLENT INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLOPLAST MANUFACTURING US LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LAKE REGION MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDI-GLOBE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOMETRICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 288 |
Tip | 283 |
Peeled / Delaminated | 132 |
Material Separation | 39 |
Break | 24 |
Guidewire | 19 |
Migration Or Expulsion Of Device | 19 |
Fracture | 13 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Improper Or Incorrect Procedure Or Method | 6 |
Flaked | 6 |
Positioning Problem | 6 |
Device Damaged By Another Device | 5 |
Material Deformation | 5 |
Material Frayed | 5 |
Unraveled Material | 4 |
Material Integrity Problem | 4 |
Detachment Of Device Or Device Component | 4 |
Device Damaged Prior To Use | 3 |
Device-Device Incompatibility | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Material Fragmentation | 3 |
Off-Label Use | 3 |
Tube | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Coil | 2 |
Difficult To Advance | 2 |
Entrapment Of Device | 2 |
Cut In Material | 2 |
Device Operates Differently Than Expected | 2 |
Bent | 2 |
Material Disintegration | 2 |
Seal | 2 |
Use Of Device Problem | 1 |
Device Dislodged Or Dislocated | 1 |
No Apparent Adverse Event | 1 |
Difficult To Remove | 1 |
Migration | 1 |
Component Falling | 1 |
Scratched Material | 1 |
Image Display Error / Artifact | 1 |
Unsealed Device Packaging | 1 |
Device Packaging Compromised | 1 |
Material Protrusion / Extrusion | 1 |
Wire(s), Breakage Of | 1 |
| Total Device Problems | 920 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | NEO METRICS, INC. | II | Jun-10-2014 |