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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 K242774
Device Name SpydrBlade Flex Instrument (PRD-RG1-001)
Applicant
Creo Medical, Ltd.
Unit 2 Beaufort Park
Beaufort Park Way
Chepstow,  GB NP16 5UH
Applicant Contact Diane Davis
Correspondent
Creo Medical, Ltd.
Unit 2 Beaufort Park
Beaufort Park Way
Chepstow,  GB NP16 5UH
Correspondent Contact Diane Davis
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/13/2024
Decision Date 06/06/2025
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
Predetermined Change
Control Plan Authorized		 No
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