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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K183594
Device Name Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J
Applicant
New Deantronics Taiwan , Ltd.
12f, # 51, Sec. 4, Chong Yang Rd., Tucheng Dist.,
New Taipei City,  TW 23675
Applicant Contact Jane Liu
Correspondent
Coombs Medical Device Consulting, Inc.
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact Craig J. Coombs
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/21/2018
Decision Date 02/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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