510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K980895Substantially Equivalent

Allegro Ultrasonic Soft Tissue Aspirator

California Institute of Tissue Eng. & Instrumenti, Visalia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980895 is the FDA 510(k) clearance record for ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR, cleared for California Institute of Tissue Eng. & Instrumenti on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list one 510(k) clearance for California Institute of Tissue Eng. & Instrumenti. As of , FDA records show no recalls naming K980895.

Clearance record

Decision date
Received
(242 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
California Institute of Tissue Eng. & Instrumenti 205 S. W. St., Suite A, Visalia CA
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