ANCHORSURE
FDA 510(k) clearance K120831 · decided 2012-10-12
Clearance details
- K-number
- K120831
- Device name
- ANCHORSURE
- Applicant
- Neomedic International S.L.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-19
- Decision date
- 2012-10-12
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- PBQ
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.