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FDA 510(k), K143404, SurgiQuest AirSeal iFS System
FDA 510(k), K143404, SurgiQuest AirSeal iFS System
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510(K) Number: K143404
Device Name: SurgiQuest AirSeal iFS System
Manufacturer: SURGIQUEST, INC.
Device Classification Name: insufflator, laparoscopic
Regulation Number: 884.1730
Classification Product Code: HIF
Date Received: 11/28/2014
Decision Date: 03/20/2015
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: SurgiQuest AirSeal iFS System
Manufacturer: SURGIQUEST, INC.
Device Classification Name: insufflator, laparoscopic
Regulation Number: 884.1730
Classification Product Code: HIF
Date Received: 11/28/2014
Decision Date: 03/20/2015
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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