Follicle Aspiration Set
FDA 510(k) clearance K161970 · decided 2017-06-14
Clearance details
- K-number
- K161970
- Device name
- Follicle Aspiration Set
- Applicant
- Vitrolife Sweden AB
- Decision
- Substantially Equivalent
- Date received
- 2016-07-18
- Decision date
- 2017-06-14
- Days to decision
- 331 days
- Clearance type
- Traditional
- Product code
- MQE
- Device class
- 2
- Regulation number
- 884.6100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Västra Frölunda, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.