Mosie Baby Kit
FDA 510(k) clearance K231203 · decided 2023-11-29
Clearance details
- K-number
- K231203
- Device name
- Mosie Baby Kit
- Applicant
- Mosie Baby
- Decision
- Substantially Equivalent
- Date received
- 2023-04-27
- Decision date
- 2023-11-29
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- QYZ
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mosie Baby
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| PherDal® At-Home Insemination Kit (K231645) | Pherdal Fertility Science, Inc. | 2023-12-14 |
Recalls involving this device
No recalls on record reference this clearance.