510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941207Substantially Equivalent

Monopolar Suction Cannula; Monopolar Electrodes

New Eder Corp., Elk Groove Village IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941207 is the FDA 510(k) clearance record for MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES, a class II device, cleared for New Eder Corp. on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 4 510(k) clearances for New Eder Corp., from to . As of , FDA records show no recalls naming K941207.

Clearance record

Decision date
Received
(316 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
New Eder Corp. 1451-E Landmeier Rd., Elk Groove Village IL
510(k) summary
Statement
Third party review
No

Clearances, product code KNF

Trailing 12 months
1 clearance under product code KNF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNF, 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 20261
October 20260