510(k) K241185

CORGRIP* SR NG/NI Tube Retention System by Avanos Medical, Inc. — Product Code KNT

K241185 is an FDA 510(k) premarket notification submitted by Avanos Medical, Inc. for the device "CORGRIP* SR NG/NI Tube Retention System". The FDA issued a decision of Substantially Equivalent on October 25, 2024. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Avanos Medical, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2024
Date Received
April 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type