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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 a medical device manufactured by Creo Medical, Ltd.. It received FDA 510(k) clearance on 2020-03-19 under approval 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. It is manufactured by Creo Medical, Ltd.. The 510(k) number is K192905.

When was Creo Electrosurgical System with HS1 Hemostasis Accessory approved by the FDA?

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

What company makes Creo Electrosurgical System with HS1 Hemostasis Accessory?

Creo Electrosurgical System with HS1 Hemostasis Accessory is manufactured by Creo Medical, Ltd..

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.

Related Clinical Trials

NCT06328647 Quantra Point-of-Care Hemostasis Monitoring ACTIVE_NOT_RECRUITING NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT05399537 Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT RECRUITING NCT06020573 Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection COMPLETED NCT04849884 To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System. ACTIVE_NOT_RECRUITING NCT07495137 The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection NOT_YET_RECRUITING

Other Devices by Creo Medical, Ltd.

K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory K200003NP1 Instrument, Creo Electrosurgical System K200298ABI Instrument, Creo Electrosurgical System K230328Speedboat Flush SB1 Instrument K223138AB1 Electrosurgical Instrument, Creo Electrosurgical System K221672Creo Electrosurgical System with NP1 Instrument

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Related Devices (Code: KNS)

K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd. K160417Rezum SystemNxthera, Inc. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.

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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