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)

MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)

K-Number: K072870 · 2008-01-14

ApplicantFoundry Newco X, Inc.
Decision Date2008-01-14
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) is the device name listed in this FDA 510(k) record. The listed applicant is Foundry Newco X, Inc.. It received FDA 510(k) clearance on 2008-01-14 under 510(k) number K072870. 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 MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)?

MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) is a medical device that received FDA 510(k) clearance on 2008-01-14. The listed applicant is Foundry Newco X, Inc.. The 510(k) number is K072870.

When did MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) receive FDA 510(k) clearance?

MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) received FDA 510(k) clearance on 2008-01-14, under 510(k) number K072870.

Who is the listed applicant for MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)?

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

What is the FDA product code for MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)?

The FDA product code for MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) is NEY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.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.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.

↑