Product Code: MKO
FDA class 2
21 CFR 884.1690
Falloposcope
Obstetrics/Gynecology
The Falloposcope is a miniaturized endoscope designed for transcervical insertion into the fallopian tube lumen, enabling direct visualization of the tubal interior for diagnostic assessment of tubal patency, pathology, or infertility workup. Classified as a Class 2 device under 21 CFR 884.1690 within the Obstetrics and Gynecology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
26
Basic Information
- Product Code
- MKO
- Device Class
- FDA class 2
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221965 | FemDx FalloView | Mar 17, 2023 | Substantially Equivalent | FemDx Medsystems, Inc. |
| K974028 | STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING | Jan 21, 1998 | Substantially Equivalent | CONCEPTUS, INC. |
| K963580 | IMAGYN FALLOPOSCOPY SYSTEM | Jan 31, 1997 | Substantially Equivalent | IMAGYN MEDICAL, INC. |
| K962587 | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM | Jan 31, 1997 | Substantially Equivalent | CONCEPTUS, INC. |