Definition: Exempt Hysteroscope Accessories Are Non-powered, Non-inflatable, Simple Manual Mechanical Devices, E.g., Cannula, Graspers, Forceps, Dissectors, Scissors, Etc. A Hysteroscope Is A Device Used To Permit Direct Viewing Of The Cervical Canal And The Ute
| Device Type ID | 4051 |
| Device Name | Hysteroscope Accessories |
| Physical State | Metal Instruments |
| Technical Method | Part Of System That Advances Through The Working Channel Of The Hysteroscope To Perform It's Function. |
| Target Area | Uterus |
| Regulation Description | Hysteroscope And Accessories. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 884.1690 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NWW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4051 |
| Device | Hysteroscope Accessories |
| Product Code | NWW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hysteroscope And Accessories. |
| CFR Regulation Number | 884.1690 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 1 |
Material Opacification | 1 |
| Total Device Problems | 2 |