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FDA 510(k)

Rezum System

K-Number: K180237 · 2018-02-27

ApplicantNxthera, Inc.
Decision Date2018-02-27
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rezum System is a medical device manufactured by Nxthera, Inc.. It received FDA 510(k) clearance on 2018-02-27 under approval number K180237. 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 2018-02-27. It is manufactured by Nxthera, Inc.. The 510(k) number is K180237.

When was Rezum System approved by the FDA?

Rezum System received FDA 510(k) clearance on 2018-02-27, under approval number K180237.

What company makes Rezum System?

Rezum System is manufactured by Nxthera, Inc..

What is the FDA product code for Rezum System?

The FDA product code for Rezum System is KNS.

Other Devices by Nxthera, Inc.

K160417Rezum System

Related Devices (Code: KNS)

K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd. K160417Rezum SystemNxthera, Inc. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.

Official Source

View on FDA Database →

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

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