CryoRobot Select System
FDA 510(k) clearance K221086 · decided 2022-11-04
Clearance details
- K-number
- K221086
- Device name
- CryoRobot Select System
- Applicant
- Tmrw Life Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-13
- Decision date
- 2022-11-04
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- QUJ
- Device class
- 2
- Regulation number
- 884.6120
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.