LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
FDA 510(k) clearance K113572 · decided 2012-09-05
Clearance details
- K-number
- K113572
- Device name
- LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
- Applicant
- Covidien, Formerly Valleylab, A Division of Tyco H
- Decision
- Substantially Equivalent
- Date received
- 2011-12-02
- Decision date
- 2012-09-05
- Days to decision
- 278 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
- Boulder, CO, 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.