Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181418
Device Classification Name
Endoscopic Irrigation/Suction System
More FDA Info for this Device
510(K) Number
K181418
Device Name
Endoscopic Irrigation/Suction System
Applicant
Partnership Medical Limited
Hartley House, Galveston Grove
Fenton ST43PE GB
Other 510(k) Applications for this Company
Contact
Rob Hartley
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
OCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/31/2018
Decision Date
07/11/2019
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