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FDA 510(k), K172227, Endoscopic Injection Needle
FDA 510(k), K172227, Endoscopic Injection Needle
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510(K) Number: K172227
Device Name: Endoscopic Injection Needle
Manufacturer: Andrew J. Adams
Device Classification Name: Endoscopic Injection Needle, Gastroenterology-Urology
Regulation Number: FBK
Classification Product Code: KXA
Date Received: 07/25/2017
Decision Date: 08/23/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Endoscopic Injection Needle
Manufacturer: Andrew J. Adams
Device Classification Name: Endoscopic Injection Needle, Gastroenterology-Urology
Regulation Number: FBK
Classification Product Code: KXA
Date Received: 07/25/2017
Decision Date: 08/23/2017
Decision: Substantially Equivalent (SESE)
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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