510(k) K951309

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

K951309 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 May 17, 1995. 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
May 17, 1995
Date Received
March 22, 1995
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