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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K171983
Device Name Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
Creo Medical Ltd
Riverside Court, Beaufort Park
Chepstow,  GB NP16 5uh
Applicant Contact Keith Penny
Creo Medical Ltd.
Riverside Court, Beaufort Park
Chepstow,  GB NP16 5uh
Correspondent Contact Keith Penny
Regulation Number876.4300
Classification Product Code
Date Received06/30/2017
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No