| Device Type ID | 5574 |
| Device Name | Clip, Implantable |
| 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) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FZP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5574 |
| Device | Clip, Implantable |
| Product Code | FZP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Clip. |
| CFR Regulation Number | 878.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMSEL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ATRICURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
CONMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ETHICON ENDO-SURGERY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LEMAITRE VASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOVA BIOMATERIALS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TAIWAN SURGICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VESOCCLUDE MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Misfire | 767 |
Failure To Form Staple | 766 |
Mechanics Altered | 667 |
Difficult To Open Or Close | 652 |
Failure To Adhere Or Bond | 558 |
Mechanical Jam | 496 |
Activation, Positioning Or Separation Problem | 416 |
Mechanical Problem | 369 |
Break | 347 |
Premature Activation | 168 |
Unintended Ejection | 166 |
Clip | 119 |
Device Slipped | 112 |
Material Deformation | 97 |
Adverse Event Without Identified Device Or Use Problem | 94 |
Detachment Of Device Component | 93 |
Failure To Fire | 91 |
Loss Of Or Failure To Bond | 90 |
Device Operates Differently Than Expected | 89 |
Detachment Of Device Or Device Component | 70 |
Failure To Align | 62 |
Entrapment Of Device | 53 |
Unintended Movement | 48 |
Positioning Failure | 48 |
Component Falling | 46 |
Fail-Safe Problem | 45 |
Device Dislodged Or Dislocated | 31 |
Migration Or Expulsion Of Device | 31 |
Separation Failure | 29 |
Failure To Advance | 27 |
Difficult To Remove | 26 |
Physical Resistance | 23 |
Display Or Visual Feedback Problem | 23 |
Material Fragmentation | 21 |
Appropriate Term/Code Not Available | 21 |
Jaw | 19 |
Difficult Or Delayed Positioning | 19 |
Tear, Rip Or Hole In Device Packaging | 17 |
Fracture | 15 |
Bent | 13 |
Unsealed Device Packaging | 13 |
Noise, Audible | 13 |
Premature Separation | 13 |
Use Of Device Problem | 11 |
Component Missing | 11 |
Loose Or Intermittent Connection | 10 |
Insufficient Information | 9 |
Positioning Problem | 8 |
Material Twisted / Bent | 8 |
Difficult To Insert | 7 |
Crack | 7 |
Difficult To Position | 6 |
Device Packaging Compromised | 6 |
Expulsion | 6 |
Material Protrusion / Extrusion | 6 |
Dent In Material | 6 |
Sticking | 6 |
Defective Component | 6 |
Product Quality Problem | 6 |
Material Integrity Problem | 5 |
Device Fell | 5 |
Retraction Problem | 5 |
Torn Material | 5 |
Firing Problem | 5 |
Malposition Of Device | 4 |
Load | 4 |
Image Display Error / Artifact | 4 |
Leak / Splash | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Physical Resistance / Sticking | 4 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 4 |
Patient-Device Incompatibility | 4 |
Precipitate In Device Or Device Ingredient | 3 |
Device Operational Issue | 3 |
Tip | 3 |
Manifold | 3 |
Chemical Problem | 3 |
Activation Failure Including Expansion Failures | 3 |
Material Separation | 3 |
Defective Device | 3 |
Delivery System Failure | 3 |
Material Rupture | 3 |
Difficult To Advance | 2 |
Fluid Leak | 2 |
Ejection Problem | 2 |
Clamp | 2 |
Folded | 2 |
Device Handling Problem | 2 |
Partial Blockage | 2 |
Screw | 2 |
Excessive Cooling | 2 |
Human-Device Interface Problem | 2 |
Failure To Cycle | 2 |
Device Inoperable | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Difficult To Interrogate | 1 |
Staple | 1 |
Inflation Problem | 1 |
Gas Leak | 1 |
Disassembly | 1 |
| Total Device Problems | 7119 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AESDEX | II | Jul-13-2018 |
| 2 | Aesculap Implant Systems LLC | II | Apr-02-2018 |
| 3 | Applied Medical Resources Corp | II | May-06-2016 |
| 4 | AtriCure, Inc. | II | Feb-08-2017 |
| 5 | AtriCure, Inc. | II | Nov-09-2016 |
| 6 | LeMaitre Vascular, Inc. | II | Jul-25-2016 |
| 7 | Teleflex Medical | II | Nov-09-2017 |
| 8 | Teleflex Medical | II | Aug-03-2016 |
| 9 | Teleflex Medical | II | Feb-25-2016 |
| 10 | Teleflex Medical | II | Dec-17-2014 |