| Device Type ID | 5637 |
| Device Name | Staple, Implantable |
| Regulation Description | Implantable Staple. |
| 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 | 878.4750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GDW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5637 |
| Device | Staple, Implantable |
| Product Code | GDW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Staple. |
| CFR Regulation Number | 878.4750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C.R. BARD INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CARDICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
DEXTERA SURGICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
ETHICON ENDO-SURGERY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON ENDO-SURGERY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON ENDO-SURGERY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
EZISURG MEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GOLDEN STAPLER SURGICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JUSTRIGHT SURGICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LEXINGTON MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OPUS KSD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SURGIMATIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VIA SURGICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Failure To Fire | 10593 |
Failure To Form Staple | 3476 |
Misfire | 2988 |
Difficult To Open Or Close | 1872 |
Human-Device Interface Problem | 1332 |
Noise, Audible | 1285 |
Adverse Event Without Identified Device Or Use Problem | 1284 |
Break | 1142 |
Entrapment Of Device | 1106 |
Detachment Of Device Component | 813 |
Mechanics Altered | 738 |
Failure To Adhere Or Bond | 643 |
Difficult To Remove | 403 |
Device Displays Incorrect Message | 401 |
Detachment Of Device Or Device Component | 394 |
Failure To Cycle | 303 |
Fluid Leak | 284 |
Failure To Cut | 272 |
Device Operates Differently Than Expected | 259 |
Retraction Problem | 201 |
Device Difficult To Setup Or Prepare | 198 |
Difficult Or Delayed Positioning | 193 |
Expulsion | 166 |
Unintended Movement | 165 |
Loss Of Or Failure To Bond | 165 |
Device Inoperable | 158 |
Component Or Accessory Incompatibility | 142 |
Bent | 140 |
Use Of Device Problem | 118 |
Mechanical Jam | 118 |
Positioning Problem | 113 |
Mechanical Problem | 109 |
Physical Resistance | 103 |
Insufficient Information | 95 |
Failure To Sense | 92 |
Positioning Failure | 90 |
Air Leak | 86 |
Device Stops Intermittently | 86 |
Appropriate Term/Code Not Available | 77 |
Device Slipped | 71 |
Difficult To Position | 69 |
Failure To Read Input Signal | 64 |
Unintended System Motion | 63 |
Failure To Align | 60 |
Difficult To Advance | 56 |
Fail-Safe Problem | 55 |
Leak / Splash | 52 |
Unintended Arm Motion | 51 |
Failure To Advance | 50 |
Sticking | 44 |
Separation Failure | 44 |
Jaw | 41 |
Component Missing | 40 |
Calibration Problem | 40 |
Gas Leak | 39 |
Material Twisted / Bent | 33 |
Unintended Head Motion | 33 |
Difficult Or Delayed Activation | 31 |
Failure To Calibrate | 30 |
Failure To Charge | 29 |
Staple | 28 |
Knife | 27 |
Complete Loss Of Power | 25 |
Material Deformation | 25 |
Difficult To Insert | 24 |
Power Problem | 24 |
Calibration Error | 19 |
Component Falling | 19 |
Overheating Of Device | 18 |
Extrusion | 18 |
Physical Resistance / Sticking | 17 |
Protective Measures Problem | 17 |
Material Separation | 16 |
Packaging Problem | 16 |
Activation, Positioning Or Separation Problem | 15 |
Product Quality Problem | 14 |
Tear, Rip Or Hole In Device Packaging | 13 |
Device Contamination With Chemical Or Other Material | 13 |
Device Packaging Compromised | 11 |
Device Handling Problem | 11 |
Switch, Push Button | 11 |
Material Fragmentation | 10 |
Knob | 10 |
Improper Or Incorrect Procedure Or Method | 10 |
Device Remains Activated | 10 |
Contamination / Decontamination Problem | 9 |
Migration Or Expulsion Of Device | 9 |
Failure To Power Up | 9 |
Premature End-of-Life Indicator | 9 |
Defective Device | 9 |
Premature Activation | 9 |
Display Or Visual Feedback Problem | 9 |
Device Damaged Prior To Use | 8 |
Self-Activation Or Keying | 8 |
Backflow | 7 |
Handpiece | 7 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 7 |
Clip | 7 |
Material Protrusion / Extrusion | 7 |
Misassembly By Users | 6 |
| Total Device Problems | 33739 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | COVIDIEN MEDTRONIC | II | Jul-19-2018 |
| 2 | COVIDIEN MEDTRONIC | II | May-16-2018 |
| 3 | Cardica, Inc. | II | Dec-24-2015 |
| 4 | Covidien LLC | II | Apr-26-2018 |
| 5 | Covidien LLC | II | Mar-27-2018 |
| 6 | Covidien LLC | II | Mar-06-2018 |
| 7 | Covidien LLC | II | Feb-16-2018 |
| 8 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 9 | Ethicon Endo-Surgery Inc | II | Jan-08-2019 |
| 10 | Ethicon Endo-Surgery Inc | II | Feb-21-2018 |
| 11 | Ethicon Endo-Surgery Inc | II | May-31-2017 |
| 12 | Ethicon Endo-Surgery Inc | II | Oct-20-2016 |
| 13 | Ethicon Endo-Surgery Inc | II | May-21-2015 |
| 14 | Incisive Surgical Inc | II | Oct-05-2018 |
| 15 | Incisive Surgical Inc | II | Apr-29-2015 |
| 16 | Intuitive Surgical, Inc. | II | Jul-06-2018 |
| 17 | Justright Surgical, LLC | II | Jul-02-2015 |
| 18 | Justright Surgical, LLC | II | Sep-23-2014 |
| 19 | Laax, Inc. | I | Apr-23-2015 |
| 20 | Medtronic | II | Feb-18-2016 |