510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003824Substantially Equivalent

Omnisonics Ultrasonic Surgery System, Model Sti

Omnisonics Medical Technologies, Wilmington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003824 is the FDA 510(k) clearance record for OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI, cleared for Omnisonics Medical Technologies on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 8 510(k) clearances for Omnisonics Medical Technologies, from to . As of , FDA records show no recalls naming K003824.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Omnisonics Medical Technologies 66 Concord St., Suite A, Wilmington MA
510(k) summary
Summary
Third party review
No

Clearances, product code LFL

Trailing 12 months
1 clearance 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 20260