| Device Type ID | 1844 |
| Device Name | Holder, Needle, Gastroenterologic |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument 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) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.4730 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FHQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1844 |
| Device | Holder, Needle, Gastroenterologic |
| Product Code | FHQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument And Accessories. |
| CFR Regulation Number | 876.4730 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 148 |
Needle | 124 |
Carrier | 75 |
Retraction Problem | 46 |
Break | 44 |
Detachment Of Device Or Device Component | 43 |
Suture | 19 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Misfire | 7 |
Use Of Device Problem | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Device Contaminated During Manufacture Or Shipping | 3 |
Device Contamination With Chemical Or Other Material | 2 |
Device Packaging Compromised | 2 |
Device Handling Problem | 1 |
Mechanical Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Solder Joint Fracture | 1 |
Fracture | 1 |
Material Twisted / Bent | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 539 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Jun-08-2017 |