510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904240Substantially Equivalent

Single Use Laparscopic Electrode

Aspen Labs, Utica NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904240 is the FDA 510(k) clearance record for SINGLE USE LAPARSCOPIC ELECTRODE, a class II device, cleared for Aspen Labs on under FDA product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)). FDA records list 6 510(k) clearances for Aspen Labs, from to . As of , FDA records show no recalls naming K904240.

Clearance record

Decision date
Received
(159 days to decision)
Product code
HFG Coagulator, Laparoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Aspen Labs 310 Broad St., Utica NY
Third party review
No

Clearances, product code HFG

Trailing 12 months

FDA records hold no clearances under product code HFG in the trailing twelve months.

FDA records show no clearances under product code HFG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HFG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260