510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964111Substantially Equivalent

Lithovac Suction/aspiration Probe

E.M.S. - Electro Medical Systems SA, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964111 is the FDA 510(k) clearance record for LITHOVAC SUCTION/ASPIRATION PROBE, a class II device, cleared for Electro Medical Systems SA on under FDA product code KQT (Evacuator, Gastro-Urology). FDA records list 41 510(k) clearances for E.M.S. ELECTRO MEDICAL SYSTEMS S.A., from to . As of , FDA records show no recalls naming K964111.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KQT Evacuator, Gastro-Urology
Regulation
21 CFR 876.4370
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Electro Medical Systems SA 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code KQT

Trailing 12 months

FDA records hold no clearances under product code KQT in the trailing twelve months.

FDA records show no clearances under product code KQT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260