| Device Type ID | 1997 |
| Device Name | Ligator, Esophageal |
| Regulation Description | Hemorrhoidal Ligator. |
| 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) Exempt |
| CFR Regulation Number | 876.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MND |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1997 |
| Device | Ligator, Esophageal |
| Product Code | MND |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemorrhoidal Ligator. |
| CFR Regulation Number | 876.4400 [🔎] |
| Device Problems | |
|---|---|
Premature Activation | 145 |
Failure To Fire | 75 |
Migration Or Expulsion Of Device | 57 |
Positioning Failure | 55 |
Detachment Of Device Component | 53 |
Difficult Or Delayed Positioning | 36 |
Improper Or Incorrect Procedure Or Method | 28 |
Break | 25 |
Defective Device | 23 |
Device Operates Differently Than Expected | 23 |
Material Separation | 21 |
Adverse Event Without Identified Device Or Use Problem | 18 |
Fracture | 15 |
Compatibility Problem | 15 |
Separation Failure | 14 |
Use Of Device Problem | 13 |
Activation, Positioning Or Separation Problem | 11 |
Clip | 11 |
Detachment Of Device Or Device Component | 10 |
Difficult To Remove | 10 |
Entrapment Of Device | 9 |
Device-Device Incompatibility | 9 |
Premature Separation | 6 |
Difficult To Position | 6 |
Shelf Life Exceeded | 6 |
Human-Device Interface Problem | 4 |
Degraded | 3 |
Difficult Or Delayed Separation | 3 |
Material Integrity Problem | 2 |
Device Issue | 2 |
Mechanical Jam | 1 |
Device Handling Problem | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Accessory Incompatible | 1 |
Torn Material | 1 |
Insufficient Information | 1 |
Migration | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Guidewire | 1 |
Loss Of Or Failure To Bond | 1 |
Device Difficult To Setup Or Prepare | 1 |
Difficult To Open Or Close | 1 |
| Total Device Problems | 720 |