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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K934937
Device Name KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact JONATHAN S KAHAN
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact JONATHAN S KAHAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/12/1993
Decision Date 03/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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