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

FDA 510(k)

miraDry System

K-Number: K160141 · 2016-10-31

ApplicantMiramar Labs, Inc.
Decision Date2016-10-31
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

miraDry System is the device name listed in this FDA 510(k) record. The listed applicant is Miramar Labs, Inc.. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K160141. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the miraDry System?

miraDry System is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Miramar Labs, Inc.. The 510(k) number is K160141.

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

miraDry System received FDA 510(k) clearance on 2016-10-31, under 510(k) number K160141.

Who is the listed applicant for miraDry System?

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

What is the FDA product code for miraDry System?

The FDA product code for miraDry System is NEY.

Other records listing Miramar Labs, 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.

K180396miraDry System

Related Devices (Code: NEY)

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.

K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)Nanjing Devin Medical Technology Co., Ltd.K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation LimitedK241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.K241825Microwave Ablation AntennasCanyon Medical, Inc.K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)Varian Medical Systems, Inc.

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.

↑