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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumoperitoneum Needle
510(k) Number K844619
Device Name ENDONEEDLE
Applicant
Endotherapeutics
654 Bair Island Rd.
Suite 209
Redwood City,  CA  94063
Applicant Contact JESSICA WARRING
Correspondent
Endotherapeutics
654 Bair Island Rd.
Suite 209
Redwood City,  CA  94063
Correspondent Contact JESSICA WARRING
Regulation Number876.1500
Classification Product Code
FHO  
Date Received11/27/1984
Decision Date 01/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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