AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
FDA 510(k) clearance K180848 · decided 2018-05-01
Clearance details
- K-number
- K180848
- Device name
- AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
- Applicant
- ArthroCare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-04-02
- Decision date
- 2018-05-01
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.