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FDA 510(k)

Creo Electrosurgical System with NP1 Instrument

K-Number: K221672 · 2023-02-14

ApplicantCreo Medical, Ltd.
Decision Date2023-02-14
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Creo Electrosurgical System with NP1 Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2023-02-14 under 510(k) number K221672. 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 Creo Electrosurgical System with NP1 Instrument?

Creo Electrosurgical System with NP1 Instrument is a medical device that received FDA 510(k) clearance on 2023-02-14. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K221672.

When did Creo Electrosurgical System with NP1 Instrument receive FDA 510(k) clearance?

Creo Electrosurgical System with NP1 Instrument received FDA 510(k) clearance on 2023-02-14, under 510(k) number K221672.

Who is the listed applicant for Creo Electrosurgical System with NP1 Instrument?

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

What is the FDA product code for Creo Electrosurgical System with NP1 Instrument?

The FDA product code for Creo Electrosurgical System with NP1 Instrument 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.

NCT06689488Bronchoscopic Microwave Ablation of Lung Tissue in Surgical CandidatesRECRUITINGNCT06869122Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UKRECRUITING

Other records listing Creo Medical, Ltd. as applicant

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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.

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