INVOcell Intravaginal Culture System
FDA 510(k) clearance K222932 · decided 2023-06-22
Clearance details
- K-number
- K222932
- Device name
- INVOcell Intravaginal Culture System
- Applicant
- Invo Bioscience
- Decision
- Substantially Equivalent
- Date received
- 2022-09-26
- Decision date
- 2023-06-22
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- OYO
- Device class
- 2
- Regulation number
- 884.6165
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Sarasota, FL, US
- 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.
| Record | Firm | Date |
|---|---|---|
| INVOcell (DEN150008) | Invo Bioscience | 2015-11-02 |
Recalls involving this device
No recalls on record reference this clearance.