Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Rezum Delivery Device, Rezum Generator

K-Number: K190093 · 2019-03-25

ApplicantNxthera (A Boston Scientific Company)
Decision Date2019-03-25
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rezum Delivery Device, Rezum Generator is a medical device manufactured by Nxthera (A Boston Scientific Company). It received FDA 510(k) clearance on 2019-03-25 under approval number K190093. 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 Delivery Device, Rezum Generator?

Rezum Delivery Device, Rezum Generator is a medical device that received FDA 510(k) clearance on 2019-03-25. It is manufactured by Nxthera (A Boston Scientific Company). The 510(k) number is K190093.

When was Rezum Delivery Device, Rezum Generator approved by the FDA?

Rezum Delivery Device, Rezum Generator received FDA 510(k) clearance on 2019-03-25, under approval number K190093.

What company makes Rezum Delivery Device, Rezum Generator?

Rezum Delivery Device, Rezum Generator is manufactured by Nxthera (A Boston Scientific Company).

What is the FDA product code for Rezum Delivery Device, Rezum Generator?

The FDA product code for Rezum Delivery Device, Rezum Generator is KNS.

Related Clinical Trials

NCT06915012 Impact of Biophoton Therapy on Chronic Severe Arthritis Pain RECRUITING NCT07595835 CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT07595289 DP-DCT 1.0：A Comparative Clinical Study on the Effect of Dapagliflozin Combined With CGM Versus SMBG on Glycemic Control in Patients With Type 2 Diabetes Mellitus Based on the DP-DCT Platform NOT_YET_RECRUITING NCT07558291 Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes NOT_YET_RECRUITING NCT06024928 Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes COMPLETED

Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025) PMID: 39855465 [Review of practices concerning the delivery of an international implant card following the implantation of a medical device]. Annales pharmaceutiques francaises (2025)

Other Devices by Nxthera (A Boston Scientific Company)

K191505Rezum 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.

↑