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FDA 510(k), K161110, ClearPetra Suction-Evacuation Sheath
FDA 510(k), K161110, ClearPetra Suction-Evacuation Sheath
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$149.00 USD
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510(K) Number: K161110
Device Name: ClearPetra Suction-Evacuation Sheath
Manufacturer: WELL LEAD MEDICAL CO., LTD.
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 04/20/2016
Decision Date: 10/12/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ClearPetra Suction-Evacuation Sheath
Manufacturer: WELL LEAD MEDICAL CO., LTD.
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 04/20/2016
Decision Date: 10/12/2016
Regulation Medical Specialty: Gastroenterology/Urology
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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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