FDA 510(k) K160417, Rezum System, by Nxthera, Inc.
FDA 510(k) K160417, Rezum System, by Nxthera, Inc.
Device Classification Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number: K160417
Device Name: Rezum System
Applicant: Nxthera, Inc.
Regulation Number: 876.43
Classification Product Code: KNS
Date Received: 2016-02-16
Decision Date: 2016-03-17
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 216
Fully redacted pages: 47
Content pages: 169
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