Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Creo Medical, Ltd.. It received FDA 510(k) clearance on 2017-08-17 under approval 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. It is manufactured by Creo Medical, Ltd.. The 510(k) number is K171983.

When was Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory approved by the FDA?

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

What company makes Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory?

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory is manufactured by Creo Medical, Ltd..

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

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42096274 Nanoparticle-based approaches to tackling urinary tract biofilms. Nanomedicine (London, England) (2026)

Other Devices by Creo Medical, Ltd.

K200003NP1 Instrument, Creo Electrosurgical System K192905Creo Electrosurgical System with HS1 Hemostasis Accessory K200298ABI Instrument, Creo Electrosurgical System K230328Speedboat Flush SB1 Instrument K223138AB1 Electrosurgical Instrument, Creo Electrosurgical System K221672Creo Electrosurgical System with NP1 Instrument

View all 10 devices →

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 K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cordsWilson-Cook Medical Inc./Cook Endoscopy

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.

↑