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510(k) K131721

EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 by Comed Medical Systems Co., Ltd. — Product Code LNS

K131721 is an FDA 510(k) premarket notification submitted by Comed Medical Systems Co., Ltd. for the device "EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1". The FDA issued a decision of Substantially Equivalent on July 22, 2014. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2014
Date Received
June 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device Class
Class II
Regulation Number
876.5990
Review Panel
GU
Submission Type

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  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K172084 — Delta III Lithotripter (August 8, 2017)
  • K170122 — Delta III Lithotripter (June 28, 2017)
  • K151298 — Gemini XXP-HP (July 30, 2015)

FDA data resources