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 |
|
Device Type ID | 4013 |
Device | Single-use Internal Condom |
Product Code | MBU |
FDA Device Classification | Class 2 Medical Device |
CFR Regulation Number | 884.5340 [🔎] |