SurgiQuest AirSeal iFS System
FDA 510(k) clearance K143404 · decided 2015-03-20
Clearance details
- K-number
- K143404
- Device name
- SurgiQuest AirSeal iFS System
- Applicant
- Surgiquest, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-28
- Decision date
- 2015-03-20
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Milford, CT, US
- Third-party review
- No
- Expedited review
- No
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