| Device Type ID | 1833 |
| Device Name | Clamp, Penile |
| Regulation Description | Urological Clamp For Males. |
| 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5160 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FHA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1833 |
| Device | Clamp, Penile |
| Product Code | FHA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urological Clamp For Males. |
| CFR Regulation Number | 876.5160 [🔎] |
| Device Problems | |
|---|---|
Product Quality Problem | 4 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap Implant Systems LLC | III | Apr-11-2018 |