FDA 510(k) Application Details - K241913

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K241913
Device Name Laparoscope, General & Plastic Surgery
Applicant Intuitive Surgical Operations, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 US
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Contact Heena Khandelwal
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 07/01/2024
Decision Date 08/28/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
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 K241913


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