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510(k) K150786

Rezum System by Nxthera, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2015
Date Received
March 25, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Nxthera, Inc.

  • K180237 — Rezum System (February 27, 2018)
  • K160417 — Rezum System (March 17, 2016)

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