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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K091215
Device Name INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
Applicant
POWER MEDICAL INTERVENTIONS, INC.
2021 CABOT BLVD.
LANGHORNE,  PA  19047
Applicant Contact BARBARA J WHITMAN
Correspondent
POWER MEDICAL INTERVENTIONS, INC.
2021 CABOT BLVD.
LANGHORNE,  PA  19047
Correspondent Contact BARBARA J WHITMAN
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received04/27/2009
Decision Date 05/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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