| Device Type ID | 5634 |
| Device Name | Applier, Surgical, Clip |
| Regulation Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GDO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5634 |
| Device | Applier, Surgical, Clip |
| Product Code | GDO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 98 |
Difficult To Open Or Close | 90 |
Failure To Align | 74 |
Activation, Positioning Or Separation Problem | 58 |
Premature Activation | 31 |
Detachment Of Device Or Device Component | 31 |
Separation Failure | 27 |
Failure To Form Staple | 21 |
Adverse Event Without Identified Device Or Use Problem | 18 |
Mechanics Altered | 17 |
Entrapment Of Device | 16 |
Positioning Failure | 14 |
Unintended Ejection | 14 |
Bent | 13 |
Device Operates Differently Than Expected | 13 |
Mechanical Problem | 12 |
Difficult To Position | 12 |
Clip | 10 |
Detachment Of Device Component | 10 |
Difficult To Remove | 10 |
Loose Or Intermittent Connection | 8 |
Jaw | 7 |
Device Inoperable | 4 |
Mechanical Jam | 4 |
Material Fragmentation | 3 |
Component Falling | 3 |
Product Quality Problem | 3 |
Material Twisted / Bent | 3 |
Physical Resistance | 2 |
Failure To Fire | 2 |
Failure To Eject | 2 |
Device Dislodged Or Dislocated | 2 |
Flaked | 2 |
Device Slipped | 2 |
Insufficient Information | 2 |
Clamp | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Material Deformation | 1 |
Unintended Movement | 1 |
Partial Blockage | 1 |
Device Packaging Compromised | 1 |
Material Separation | 1 |
Device Issue | 1 |
Device Handling Problem | 1 |
Noise, Audible | 1 |
Needle | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Crack | 1 |
Premature Separation | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
Difficult Or Delayed Positioning | 1 |
Fail-Safe Problem | 1 |
Failure To Adhere Or Bond | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Failure To Advance | 1 |
| Total Device Problems | 662 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical | II | Sep-08-2016 |
| 2 | The Anspach Effort, Inc. | II | Mar-24-2016 |