Definition: To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
| Device Type ID | 2064 |
| Device Name | Endoscopic Tissue Approximation Device |
| Physical State | May Include: Delivery Instrument, Applier, Holder, Connector, Threading Tool, Needle-loading Tool, Ring Implant, Pin Implant, Knot Pusher, Sutures, Staples, Clips, Tackers, Fasteners |
| Technical Method | Many Methods To Perform Intended Use. Insert Instrument Through Endoscope At Desired Area Of Delivery. |
| Target Area | Various Tissues Located Within Body Cavities, Hollow Organs, And Canals In GI And GU Tract. |
| Regulation Description | Endoscope And Accessories. |
| 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 | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2064 |
| Device | Endoscopic Tissue Approximation Device |
| Product Code | OCW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APOLLO ENDOSURGERY INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDEON BIODESIGN, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 381 |
Human-Device Interface Problem | 277 |
Break | 212 |
Detachment Of Device Or Device Component | 155 |
Difficult To Open Or Close | 46 |
Component Or Accessory Incompatibility | 29 |
Adverse Event Without Identified Device Or Use Problem | 25 |
Mechanical Jam | 17 |
Bent | 15 |
Entrapment Of Device | 13 |
Needle | 12 |
Unraveled Material | 11 |
Device Difficult To Setup Or Prepare | 9 |
Appropriate Term/Code Not Available | 9 |
Misfire | 8 |
Mechanics Altered | 8 |
Sticking | 8 |
Failure To Align | 6 |
Torn Material | 5 |
Difficult Or Delayed Positioning | 5 |
Loose Or Intermittent Connection | 4 |
Material Fragmentation | 4 |
Insufficient Information | 3 |
Mechanical Problem | 3 |
Device Slipped | 3 |
Difficult To Remove | 3 |
Device Operates Differently Than Expected | 3 |
Material Twisted / Bent | 3 |
Handpiece | 2 |
Material Frayed | 2 |
Jaw | 2 |
Noise, Audible | 2 |
Difficult To Insert | 2 |
Difficult To Advance | 2 |
Component Falling | 1 |
Failure To Disconnect | 1 |
Premature Activation | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Out-Of-Box Failure | 1 |
Computer Operating System Problem | 1 |
Component Incompatible | 1 |
Accessory Incompatible | 1 |
Connection Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Failure To Adhere Or Bond | 1 |
Product Quality Problem | 1 |
Defective Component | 1 |
Failure To Fire | 1 |
Compatibility Problem | 1 |
Device Component Or Accessory | 1 |
Suture | 1 |
Device Operational Issue | 1 |
Patient-Device Incompatibility | 1 |
| Total Device Problems | 1309 |