510(k) K220395

EndoGator Endoscopy Irrigation Tubing by STERIS Corporation — Product Code FEQ

K220395 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "EndoGator Endoscopy Irrigation Tubing". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2022
Date Received
February 11, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Air, Non-Manual, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type