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FDA 510(k)

Creo Electrosurgical System with HS1 Hemostasis Accessory

K-Number: K192905 · 2020-03-19

ApplicantCreo Medical, Ltd.
Decision Date2020-03-19
Product CodeKNS
Advisory CommitteeGU
DecisionUnknown

Device Summary

Creo Electrosurgical System with HS1 Hemostasis 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 2020-03-19 under 510(k) number K192905. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Creo Electrosurgical System with HS1 Hemostasis Accessory?

Creo Electrosurgical System with HS1 Hemostasis Accessory is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K192905.

When did Creo Electrosurgical System with HS1 Hemostasis Accessory receive FDA 510(k) clearance?

Creo Electrosurgical System with HS1 Hemostasis Accessory received FDA 510(k) clearance on 2020-03-19, under 510(k) number K192905.

Who is the listed applicant for Creo Electrosurgical System with HS1 Hemostasis 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 Electrosurgical System with HS1 Hemostasis Accessory?

The FDA product code for Creo Electrosurgical System with HS1 Hemostasis Accessory is KNS.

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Other records listing Creo Medical, Ltd. as applicant

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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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