FemDx FalloView
FDA 510(k) clearance K221965 · decided 2023-03-17
Clearance details
- K-number
- K221965
- Device name
- FemDx FalloView
- Applicant
- Femdx Medsystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-05
- Decision date
- 2023-03-17
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- MKO
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING (K974028) | Conceptus, Inc. | 1998-01-21 |
| CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM (K962587) | Conceptus, Inc. | 1997-01-31 |
| IMAGYN FALLOPOSCOPY SYSTEM (K963580) | Imagyn Medical, Inc. | 1997-01-31 |
Recalls involving this device
No recalls on record reference this clearance.