Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K221331
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K221331
Device Name
Endoscope Channel Accessory
Applicant
Changzhou Endoclean Medical Device Co., Ltd.
West Side of 4th Floor, Building E2, No.9 Changyang Road
Changzhou 213149 CN
Other 510(k) Applications for this Company
Contact
Wang Qi
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/05/2022
Decision Date
09/08/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact