FDA 510(k) Application Details - K243182

Device Classification Name

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510(K) Number K243182
Device Name Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
Applicant Momentis Surgical Ltd.
6 Yoni Netanyahu Street
Or Yehuda 6037604 IL
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Contact Maya Leib Shlomo
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Regulation Number

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Classification Product Code QNM
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Date Received 09/30/2024
Decision Date 02/03/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K243182


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