510(k) K183336

Entuit PEG, Entuit PEGJ by Wilson-Cook Medical, Inc. — Product Code KNT

K183336 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Entuit PEG, Entuit PEGJ". The FDA issued a decision of Substantially Equivalent (kit) on May 29, 2019. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 29, 2019
Date Received
December 3, 2018
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