510(k) K964111

LITHOVAC SUCTION/ASPIRATION PROBE by Electro Medical Systems SA — Product Code KQT

K964111 is an FDA 510(k) premarket notification submitted by Electro Medical Systems SA for the device "LITHOVAC SUCTION/ASPIRATION PROBE". The FDA issued a decision of Substantially Equivalent on December 16, 1996. The device falls under product code KQT (Evacuator, Gastro-Urology), a Class II device regulated under 21 CFR 876.4370. Electro Medical Systems SA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1996
Date Received
October 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Gastro-Urology
Device Class
Class II
Regulation Number
876.4370
Review Panel
GU
Submission Type