Cleared Traditional

K964111 - LITHOVAC SUCTION/ASPIRATION PROBE

K964111 is an FDA 510(k) clearance for LITHOVAC SUCTION/ASPIRATION PROBE, manufactured by Electro Medical Systems SA. The device is a Class 2 Gastroenterology & Urology device with product code KQT cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K964111 · Electro Medical Systems SA · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
62d
Days
Class 2
Risk

K964111 is an FDA 510(k) clearance for the LITHOVAC SUCTION/ASPIRATION PROBE. Classified as Evacuator, Gastro-urology (product code KQT), Class II - Special Controls.

Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4370 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K964111

510(k) Number K964111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date December 16, 1996
Days to Decision 62 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 131d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQT Device Classification - Class 2, Special Controls

Product Code KQT Evacuator, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KQT Evacuator, Gastro-urology

All 13
Devices cleared under the same product code (KQT) and FDA review panel - the closest regulatory comparables to K964111.
EVACUATOR, GASTRO-UROLOGY
K921088 · Northgate Technologies, Inc. · Oct 1992
EVACUATOR, GASTRO-UROLOGY
K921451 · Northgate Technologies, Inc. · Oct 1992
CLEANFLOW SYSTEM
K910728 · Mitron Technologies, Inc. · Apr 1991
VAN-TEC BLADDER EVACUATOR
K880099 · Van-Tec, Inc. · Mar 1988
BELLA - VAC IRRIGATOR
K874493 · Bel-Can Industries · Feb 1988
ELLIK EVACUATOR
K860266 · R. J. Ltd., Ind. · Mar 1986
K964111 · LITHOVAC SUCTION/ASPIRATION PROBE
Download PDF FDA Summary Electro Medical Syste…