VR101 Lubricating Intravaginal Ring
FDA 510(k) clearance K203377 · decided 2021-05-20
Clearance details
- K-number
- K203377
- Device name
- VR101 Lubricating Intravaginal Ring
- Applicant
- J3 Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-17
- Decision date
- 2021-05-20
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- QPD
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.