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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 K915725
Device Name CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE
Applicant
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Applicant Contact GREGORY MATHISON
Correspondent
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Correspondent Contact GREGORY MATHISON
Regulation Number876.1500
Classification Product Code
FHO  
Date Received12/20/1991
Decision Date 11/16/1992
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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