510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K010309Substantially Equivalent

Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator

Mutoh America Co., Ltd., Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010309 is the FDA 510(k) clearance record for SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR, cleared for Mutoh America Co., Ltd. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list one 510(k) clearance for Mutoh America Co., Ltd. As of , FDA records show 4 recalls naming K010309.

Clearance record

Decision date
Received
(76 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Mutoh America Co., Ltd. P.O. Box 7007, Deer Field IL
510(k) summary
Summary
Third party review
No

Clearances, product code LFL

Trailing 12 months
2 clearances under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20261