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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K221102
Device Name LOTUS Series 4 Enhanced Shears, LOTUS Series 5
Applicant
Sra Developments, Ltd.
Bremridge House
Ashburton,  GB TQ13 7JX
Applicant Contact Phillipa Frewin
Correspondent
Sra Developments, Ltd.
Bremridge House
Ashburton,  GB TQ13 7JX
Correspondent Contact Phillipa Frewin
Classification Product Code
LFL  
Date Received04/14/2022
Decision Date 12/15/2022
Decision Substantially Equivalent (SESE)
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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