MKO — Falloposcope Class II
FDA product code MKO covers "Falloposcope", a Class II medical device regulated under 21 CFR 884.1690. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MKO
- Device Class
- Class II
- Regulation Number
- 884.1690
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221965 | femdx medsystems | FemDx FalloView | March 17, 2023 |
| K974028 | conceptus | STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING | January 21, 1998 |
| K963580 | imagyn medical | IMAGYN FALLOPOSCOPY SYSTEM | January 31, 1997 |
| K962587 | conceptus | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM | January 31, 1997 |