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FDA 510(k)

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory

K-Number: K171983 · 2017-08-17

ApplicantCreo Medical, Ltd.
Decision Date2017-08-17
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory 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 2017-08-17 under 510(k) number K171983. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory?

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K171983.

When did Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory receive FDA 510(k) clearance?

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171983.

Who is the listed applicant for Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory?

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 Medical Electrosurgical System including Speedboat RS2 Surgical Accessory?

The FDA product code for Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory is KNS.

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.

K242774SpydrBlade Flex Instrument (PRD-RG1-001)K242983CROMA Electrosurgical Generator (PRD-EMR-050)K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)K230328Speedboat Flush SB1 InstrumentK223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemK221672Creo Electrosurgical System with NP1 Instrument

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Related Devices (Code: KNS)

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.

K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems CorporationK251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical

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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