510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880166Substantially Equivalent

Bovie Ultrasonic Surgical Aspirator, Model Me2000

Clinical Technology Inc., Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880166 is the FDA 510(k) clearance record for BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000, cleared for Clinical Technology Corp. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 12 510(k) clearances for Clinical Technology Corp., from to . As of , FDA records show no recalls naming K880166.

Clearance record

Decision date
Received
(35 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Clinical Technology Corp. 1212 St. Paul St., Baltimore MD
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