Twoplus Applicator
FDA 510(k) clearance K232579 · decided 2023-12-21
Clearance details
- K-number
- K232579
- Device name
- Twoplus Applicator
- Applicant
- Hannah Life Technologies Pte , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-25
- Decision date
- 2023-12-21
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- QYZ
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Singapore, SG
- 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.
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| PherDal® At-Home Insemination Kit (K231645) | Pherdal Fertility Science, Inc. | 2023-12-14 |
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Recalls involving this device
No recalls on record reference this clearance.