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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K983925
Device Name ENDOPATH ULTRA VERESS NEEDLE
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact EDWIN O BILLIPS
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact EDWIN O BILLIPS
Regulation Number884.1730
Classification Product Code
HIF  
Date Received11/05/1998
Decision Date 02/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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