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FDA 510(k), K201808, X-Tack Endoscopic HeliX Tacking System
FDA 510(k), K201808, X-Tack Endoscopic HeliX Tacking System
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$149.00 USD
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510(K) Number: K201808
Device Name: X-Tack Endoscopic HeliX Tacking System
Manufacturer: Apollo Endosurgery, Inc.
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 07/01/2020
Decision Date: 12/15/2020
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: X-Tack Endoscopic HeliX Tacking System
Manufacturer: Apollo Endosurgery, Inc.
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 07/01/2020
Decision Date: 12/15/2020
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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