PherDal® At-Home Insemination Kit
FDA 510(k) clearance K231645 · decided 2023-12-14
Clearance details
- K-number
- K231645
- Device name
- PherDal® At-Home Insemination Kit
- Applicant
- Pherdal Fertility Science, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-05
- Decision date
- 2023-12-14
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- QYZ
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Dixon, IL, 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 |
|---|---|---|
| Twoplus Applicator (K232579) | Hannah Life Technologies Pte , Ltd. | 2023-12-21 |
| Mosie Baby Kit (K231203) | Mosie Baby | 2023-11-29 |
Recalls involving this device
No recalls on record reference this clearance.