510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894600Substantially Equivalent

Cusa System 200C,t,m,h Ultrasonic Aspirator

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894600 is the FDA 510(k) clearance record for CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR, cleared for Valleylab, Inc. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K894600.

Clearance record

Decision date
Received
(183 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Valleylab, Inc. 5920 Longbow Dr., Boulder CO
Third party review
No

Clearances, product code LFL

Trailing 12 months
3 clearances under product code LFL in the twelve months to November 2026, October 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20262
November 20260