510(k) K964079

SPEEDBAND MULTIPLE BAND LIGATOR by Boston Scientific Corp — Product Code FHN

K964079 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "SPEEDBAND MULTIPLE BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on February 13, 1997. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Boston Scientific Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1997
Date Received
October 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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