Clue Birth Control
FDA 510(k) clearance K193330 · decided 2021-02-18
Clearance details
- K-number
- K193330
- Device name
- Clue Birth Control
- Applicant
- Biowink GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-12-02
- Decision date
- 2021-02-18
- Days to decision
- 444 days
- Clearance type
- Abbreviated
- Product code
- PYT
- Device class
- 2
- Regulation number
- 884.5370
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Berlin, DE
- Third-party review
- No
- Expedited review
- No
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| Natural Cycles (K231274) | Natural Cycles Nordic AB | 2023-08-24 |
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| Natural Cycles (DEN170052) | Natural Cycles Nordic AB | 2018-08-10 |
Recalls involving this device
No recalls on record reference this clearance.