AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
FDA 510(k) clearance K132974 · decided 2013-12-03
Clearance details
- K-number
- K132974
- Device name
- AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
- Applicant
- Medtronic Advanced Energy, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-09-23
- Decision date
- 2013-12-03
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Portsmouth, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.