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FDA 510(k) Application Details - K221781
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K221781
Device Name
Laparoscope, General & Plastic Surgery
Applicant
Guangdong OptoMedic Technologies, Inc.
Suite 503, Building A, Golden Valley
Intellicreation Community, No. 2 Yonganbei Street
Foshan 528200 CN
Other 510(k) Applications for this Company
Contact
Jane Guo
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/21/2022
Decision Date
02/02/2023
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
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