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)

ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I

K-Number: K094021 · 2010-08-06

ApplicantMicrosulis Medical Limited
Decision Date2010-08-06
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I is the device name listed in this FDA 510(k) record. The listed applicant is Microsulis Medical Limited. It received FDA 510(k) clearance on 2010-08-06 under 510(k) number K094021. 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 ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I?

ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I is a medical device that received FDA 510(k) clearance on 2010-08-06. The listed applicant is Microsulis Medical Limited. The 510(k) number is K094021.

When did ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I receive FDA 510(k) clearance?

ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I received FDA 510(k) clearance on 2010-08-06, under 510(k) number K094021.

Who is the listed applicant for ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I?

The FDA 510(k) record lists Microsulis Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I?

The FDA product code for ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I 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

Other records listing Microsulis Medical Limited 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.

K122762ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR

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.

↑