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FDA 510(k)

Rezum System

K-Number: K160417 · 2016-03-17

ApplicantNxthera, Inc.
Decision Date2016-03-17
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rezum System is the device name listed in this FDA 510(k) record. The listed applicant is Nxthera, Inc.. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K160417. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rezum System?

Rezum System is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Nxthera, Inc.. The 510(k) number is K160417.

When did Rezum System receive FDA 510(k) clearance?

Rezum System received FDA 510(k) clearance on 2016-03-17, under 510(k) number K160417.

Who is the listed applicant for Rezum System?

The FDA 510(k) record lists Nxthera, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rezum System?

The FDA product code for Rezum System is KNS.

Other records listing Nxthera, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180237Rezum System

Related Devices (Code: KNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems CorporationK251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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