Definition: For Contraception And/or Prophylactic (preventing The Transmission Of Sexually Transmitted Infections) Purposes. At The Conclusion Of Coitus, It Is Removed And Discarded.
| Device Type ID | 4013 |
| Device Name | Single-use Internal Condom |
| Physical State | A Single-use Internal Condom Is A Sheath-like Device That Lines The Vaginal Or Anal Wall And Is Inserted Into The Vagina Or Anus Prior To The Initiation Of Coitus. |
| Technical Method | The Device Is Inserted Into The Vagina Or Anus. |
| Target Area | Vagina Or Anus |
| 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) |
| CFR Regulation Number | 884.5340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MBU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 4013 |
| Device | Single-use Internal Condom |
| Product Code | MBU |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 884.5340 [🔎] |