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FDA 510(k), K180689, Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
FDA 510(k), K180689, Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
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$149.00 USD
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510(K) Number: K180689
Device Name: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
Manufacturer: STERIS Corporation
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 03/15/2018
Decision Date: 04/12/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
Manufacturer: STERIS Corporation
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 03/15/2018
Decision Date: 04/12/2018
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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