510(k) K970121

STONE DISLODGER, BASKET by Boston Scientific Corp — Product Code FGO

K970121 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "STONE DISLODGER, BASKET". The FDA issued a decision of Substantially Equivalent on April 2, 1997. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. Boston Scientific Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1997
Date Received
January 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Flexible
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type