510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051947Substantially Equivalent

Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone

Radionics, A Division of Tyco Healthcare Group LP, Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051947 is the FDA 510(k) clearance record for RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE, cleared for Radionics, A Division of Tyco Healthcare Group LP on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 8 510(k) clearances for Radionics, A Division of Tyco Healthcare Group LP, from to . As of , FDA records show no recalls naming K051947.

Clearance record

Decision date
Received
(35 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Radionics, A Division of Tyco Healthcare Group LP 22 Terry Ave., Burlington MA
510(k) summary
Summary PDF
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