510(k) K964111
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