Definition: The "implantable Clip, Reprocessed" Is Intended To Connect Internal Tissues To Aid In Healing. It Is Not Absorbable. This Device Is Indicated For Reuse/reprocessing.
| Device Type ID | 5771 |
| Device Name | Clip, Implantable, Reprocessed |
| Regulation Description | Implantable Clip. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NMJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5771 |
| Device | Clip, Implantable, Reprocessed |
| Product Code | NMJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Clip. |
| CFR Regulation Number | 878.4300 [🔎] |
| Device Problems | |
|---|---|
Clip | 36 |
Material Deformation | 26 |
Device Operates Differently Than Expected | 18 |
Misfire | 8 |
Failure To Adhere Or Bond | 7 |
Failure To Form Staple | 6 |
Mechanical Problem | 6 |
Insufficient Information | 4 |
Material Twisted / Bent | 4 |
Failure To Cycle | 4 |
Failure To Fire | 3 |
Device Ingredient Or Reagent Problem | 3 |
Product Quality Problem | 2 |
Difficult Or Delayed Positioning | 2 |
Break | 2 |
Premature Activation | 1 |
Failure To Align | 1 |
Mechanics Altered | 1 |
Positioning Failure | 1 |
Sticking | 1 |
Failure To Fold | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
Difficult To Open Or Close | 1 |
| Total Device Problems | 140 |