Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K221898
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K221898
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
ReShape Lifesciences
1001 Calle Amanecer
San Clemente, CA 92673 US
Other 510(k) Applications for this Company
Contact
Michelle Ravert
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2022
Decision Date
07/28/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact