510(k) K021991

MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE by Syncro Medical Innovations, Inc. — Product Code KNT

K021991 is an FDA 510(k) premarket notification submitted by Syncro Medical Innovations, Inc. for the device "MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on July 18, 2002. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Syncro Medical Innovations, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2002
Date Received
June 18, 2002
Clearance Type
Special
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