510(k) K071066

SPYCATCH STONE RETRIEVAL BASKET by Boston Scientific Corp — Product Code LQR

K071066 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "SPYCATCH STONE RETRIEVAL BASKET". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Boston Scientific Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2007
Date Received
April 16, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type