510(k) K221965
- Device
- FemDx FalloView
- Applicant
- Femdx Medsystems, Inc.
- 510(k) number
- K221965
- Product code
- MKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-17
- Date received
- 2022-07-05
- Regulation
- 884.1690
- Classification name
- Falloposcope
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PeiJie Cao
- Address
- 2336 Walsh Ave. Suite A Santa Clara CA US 95051 95051
Source Documents#
Other 510(k) Records For Product Code MKO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974028 | STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING | Conceptus, Inc. | 1998-01-21 |
| K962587 | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM | Conceptus, Inc. | 1997-01-31 |
| K963580 | IMAGYN FALLOPOSCOPY SYSTEM | Imagyn Medical, Inc. | 1997-01-31 |