| Device Type ID | 1841 |
| Device Name | Ligator, Hemorrhoidal |
| 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 | FHN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1841 |
| Device | Ligator, Hemorrhoidal |
| Product Code | FHN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemorrhoidal Ligator. |
| CFR Regulation Number | 876.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AGENCY FOR MEDICAL INNOVATIONS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Positioning Failure | 511 |
Premature Activation | 259 |
Failure To Fire | 116 |
Break | 114 |
Appropriate Term/Code Not Available | 47 |
Separation Failure | 44 |
Suture | 42 |
Detachment Of Device Or Device Component | 32 |
Failure To Adhere Or Bond | 26 |
Wire | 22 |
Difficult Or Delayed Positioning | 17 |
Defective Device | 13 |
Misfire | 10 |
Defective Component | 8 |
Detachment Of Device Component | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Failure To Advance | 4 |
Migration Or Expulsion Of Device | 4 |
Difficult To Remove | 3 |
Activation, Positioning Or Separation Problem | 3 |
Loss Of Or Failure To Bond | 3 |
Human-Device Interface Problem | 2 |
Material Separation | 2 |
Component Or Accessory Incompatibility | 1 |
Material Fragmentation | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Deformation | 1 |
Difficult To Advance | 1 |
Fracture | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 1300 |