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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Surgical, Computer Controlled Instrument, Remanufactured
510(k) Number K250399
Device Name Remanufactured EndoWrist Cadiere Forceps (420049)
Applicant
Rebotix
539 Pasadena Ave. S.
St. Petersburg,  FL  33707
Applicant Contact Chris Gibson
Correspondent
Ajw Technology Consultants, Inc.
11705 Boyette Rd. #503
Riverview,  FL  33569
Correspondent Contact Alexsis Torres
Regulation Number876.1500
Classification Product Code
QSM  
Subsequent Product Code
NAY  
Date Received02/12/2025
Decision Date 08/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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