510(k) K910492

BARD REPLACEMENT GASTROSTOMY TUBE by C.R. Bard, Inc. — Product Code KGC

K910492 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD REPLACEMENT GASTROSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on July 24, 1991. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1991
Date Received
February 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type