K232579
- 510(k) number
- K232579
- Device name
- Twoplus Applicator
- Applicant
- Hannah Life Technologies Pte , Ltd. SG
- Product code
- QYZ — At Home Intravaginal Insemination System
- Decision date
- 2023-12-21
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232579
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.