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FDA 510(k), K192697, Instinct Plus Endoscopic Clipping Device
FDA 510(k), K192697, Instinct Plus Endoscopic Clipping Device
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510(K) Number: K192697
Device Name: Instinct Plus Endoscopic Clipping Device
Manufacturer: Cook Endoscopy
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 09/26/2019
Decision Date: 03/05/2020
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Instinct Plus Endoscopic Clipping Device
Manufacturer: Cook Endoscopy
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 09/26/2019
Decision Date: 03/05/2020
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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