510(k) K102548

FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE by Footprint Medical, Inc. — Product Code KNT

K102548 is an FDA 510(k) premarket notification submitted by Footprint Medical, Inc. for the device "FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on November 26, 2010. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Footprint Medical, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2010
Date Received
September 3, 2010
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