Meridian Vaginal Positioning System (VPS)
FDA 510(k) clearance K173501 · decided 2018-02-09
Clearance details
- K-number
- K173501
- Device name
- Meridian Vaginal Positioning System (VPS)
- Applicant
- Coloplast
- Decision
- Substantially Equivalent
- Date received
- 2017-11-13
- Decision date
- 2018-02-09
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- PWK
- Device class
- 2
- Regulation number
- 884.4910
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.