Definition: To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.
| Device Type ID | 2067 |
| Device Name | Endoscopic Grasping/cutting Instrument, Non-powered |
| Physical State | Non-electric And Non-magnetic Devices. May Include: Grasping Or Retrieval Forceps, Biopsy Forceps Or Other Sampling Tools, Scissors, Stone Basket, Stone Dislodger |
| Technical Method | Place Through An Endoscope To Reach Desired Area. |
| Target Area | Various Tissues, Stones Or Other Foreign Bodies Within 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) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2067 |
| Device | Endoscopic Grasping/cutting Instrument, Non-powered |
| Product Code | OCZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MICRO-TECH (NAN JING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SLATER ENDOSCOPY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insulation | 154 |
Device Operates Differently Than Expected | 82 |
Crack | 42 |
Device Packaging Compromised | 38 |
Break | 36 |
Handpiece | 14 |
Shaft | 12 |
Tip | 12 |
Mechanics Altered | 12 |
Peeled / Delaminated | 11 |
Material Integrity Problem | 10 |
Device Inoperable | 3 |
Difficult To Remove | 3 |
Component Missing | 2 |
Material Separation | 2 |
Material Fragmentation | 1 |
Misassembly By Users | 1 |
Device Handling Problem | 1 |
Detachment Of Device Component | 1 |
Hinge | 1 |
Mechanical Problem | 1 |
Device Or Device Fragments Location Unknown | 1 |
Detachment Of Device Or Device Component | 1 |
Naturally Worn | 1 |
No Apparent Adverse Event | 1 |
Jaw | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Material Discolored | 1 |
| Total Device Problems | 446 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | US Endoscopy Group Inc | II | Apr-16-2015 |