Transvaginal Access Platform
FDA 510(k) clearance K191294 · decided 2019-09-06
Clearance details
- K-number
- K191294
- Device name
- Transvaginal Access Platform
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-14
- Decision date
- 2019-09-06
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- HEW
- Device class
- 2
- Regulation number
- 884.1640
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Rancho Santa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.