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FDA 510(k)

NP1 Instrument, Creo Electrosurgical System

K-Number: K200003 · 2020-10-28

ApplicantCreo Medical, Ltd.
Decision Date2020-10-28
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NP1 Instrument, Creo Electrosurgical System 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 2020-10-28 under 510(k) number K200003. 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 NP1 Instrument, Creo Electrosurgical System?

NP1 Instrument, Creo Electrosurgical System is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K200003.

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

NP1 Instrument, Creo Electrosurgical System received FDA 510(k) clearance on 2020-10-28, under 510(k) number K200003.

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

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 NP1 Instrument, Creo Electrosurgical System?

The FDA product code for NP1 Instrument, Creo Electrosurgical System 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

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.

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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.

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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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