510(k) K022434

BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U by C.R. Bard, Inc. — Product Code MND

K022434 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U". The FDA issued a decision of Substantially Equivalent on August 5, 2002. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2002
Date Received
July 25, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Ligator, Esophageal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type