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FDA 510(k), K173400, ORISE Tissue Retractor System
FDA 510(k), K173400, ORISE Tissue Retractor System
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510(K) Number: K173400
Device Name: ORISE Tissue Retractor System
Manufacturer: Boston Scientific
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 10/31/2017
Decision Date: 02/09/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ORISE Tissue Retractor System
Manufacturer: Boston Scientific
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 10/31/2017
Decision Date: 02/09/2018
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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