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FDA 510(k), K152001, Sterile Repositionable Hemostasis Clipping Device
FDA 510(k), K152001, Sterile Repositionable Hemostasis Clipping Device
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510(K) Number: K152001
Device Name: Sterile Repositionable Hemostasis Clipping Device
Manufacturer: Micro-Tech (Nanjing) CO.,Ltd.
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 07/20/2015
Decision Date: 12/10/2015
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Sterile Repositionable Hemostasis Clipping Device
Manufacturer: Micro-Tech (Nanjing) CO.,Ltd.
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 07/20/2015
Decision Date: 12/10/2015
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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