Definition: Clip Placement Within The Gastrointestinal (GI) Tract For The Purpose Of Endoscopic Marking, Hemostasis For Mucosal/sub-mucosal Defects, Bleeding Ulcers, Arteries, Polyps, Diverticula In The Colon, Prophylactic Clipping, Anchoring Feeding Tubes, Supp
| Device Type ID | 2104 |
| Device Name | Hemostatic Metal Clip For The Gi Tract |
| Physical State | Metal Clips Applied By A Delivery System |
| Technical Method | Applies Pressure To Tissue |
| Target Area | Gastrointestinal Tract |
| Regulation Description | Hemorrhoidal Ligator. |
| 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) |
| CFR Regulation Number | 876.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PKL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2104 |
| Device | Hemostatic Metal Clip For The Gi Tract |
| Product Code | PKL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemorrhoidal Ligator. |
| CFR Regulation Number | 876.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HANGZHOU AGS MEDTECH CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO-TECH (NAN JING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MICRO-TECH (NANJING) CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OVESCO ENDOSCOPY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Activation, Positioning Or Separation Problem | 726 |
Clip | 534 |
Premature Activation | 100 |
Separation Failure | 41 |
Break | 27 |
Failure To Advance | 24 |
Material Deformation | 17 |
Bushing | 14 |
Adverse Event Without Identified Device Or Use Problem | 13 |
Fracture | 10 |
Use Of Device Problem | 9 |
Detachment Of Device Component | 8 |
Positioning Failure | 6 |
Difficult To Open Or Close | 5 |
Contamination / Decontamination Problem | 4 |
Detachment Of Device Or Device Component | 4 |
Material Fragmentation | 3 |
Migration Or Expulsion Of Device | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Failure To Adhere Or Bond | 2 |
Device Operates Differently Than Expected | 2 |
Human-Device Interface Problem | 2 |
Material Protrusion / Extrusion | 2 |
Defective Device | 2 |
Positioning Problem | 2 |
Entrapment Of Device | 1 |
Component(s), Broken | 1 |
Device Packaging Compromised | 1 |
Off-Label Use | 1 |
Peeled / Delaminated | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Difficult To Remove | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Failure To Fire | 1 |
Device Fell | 1 |
Difficult Or Delayed Positioning | 1 |
Device Dislodged Or Dislocated | 1 |
Seal | 1 |
| Total Device Problems | 1576 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | US Endoscopy Group Inc | II | Mar-13-2019 |