Definition: To Measure Testicular Volume To Diagnose Abnormalities, Or To Determine The Size Of Testicular Prosthesis To Implant.
| Device Type ID | 2078 |
| Device Name | Orchidometer |
| Physical State | The Orchidometer Consists Of A Set Of Oval Beads Of Various Known Volumes. |
| Technical Method | To The Patients Testes To Oval Beads Of Known Volume. |
| Target Area | The Orchidometer Is Held Next To The Patient's Scrotum. |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.4730 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OLH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2078 |
| Device | Orchidometer |
| Product Code | OLH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument And Accessories. |
| CFR Regulation Number | 876.4730 [🔎] |