| Device Type ID | 1752 |
| Device Name | Forceps, Biopsy, Non-electric |
| Regulation Description | Gastroenterology-urology Biopsy Instrument. |
| 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 | 876.1075 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FCL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1752 |
| Device | Forceps, Biopsy, Non-electric |
| Product Code | FCL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Gastroenterology-urology Biopsy Instrument. |
| CFR Regulation Number | 876.1075 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 246 |
Adverse Event Without Identified Device Or Use Problem | 64 |
Material Separation | 33 |
Dull, Blunt | 28 |
Break | 25 |
Device Contamination With Chemical Or Other Material | 22 |
Failure To Align | 21 |
Device Handling Problem | 15 |
Solder Joint Fracture | 7 |
Material Fragmentation | 5 |
Difficult To Remove | 4 |
Use Of Device Problem | 3 |
Difficult To Open Or Close | 3 |
Detachment Of Device Component | 3 |
Detachment Of Device Or Device Component | 3 |
Mechanical Problem | 2 |
Jaw | 2 |
Bent | 2 |
Fracture | 2 |
Cups | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Sparking | 1 |
Human-Device Interface Problem | 1 |
Material Integrity Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Wire | 1 |
Failure To Cut | 1 |
Premature Activation | 1 |
Needle | 1 |
Difficult To Advance | 1 |
Failure To Obtain Sample | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Device-Device Incompatibility | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Off-Label Use | 1 |
Material Protrusion / Extrusion | 1 |
| Total Device Problems | 507 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Aug-22-2016 |