FDA 510(k) Application Details - K191555

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K191555
Device Name Instrument, Ultrasonic Surgical
Applicant Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo, PR 00969 US
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Contact Nathan Anderson
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 06/12/2019
Decision Date 02/28/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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