510(k) K902170

SOEHENDRA LITHOTRIPSY SET by Wilson-Cook Medical, Inc. — Product Code LQC

K902170 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "SOEHENDRA LITHOTRIPSY SET". The FDA issued a decision of Substantially Equivalent on July 25, 1990. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1990
Date Received
May 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Biliary Mechanical
Device Class
Class II
Regulation Number
876.4500
Review Panel
GU
Submission Type